Medical Devices

File Layout for Releasable 510(k)s

POSITION		DESCRIPTION
1-9		510(K) NUMBER
10-59		APPLICANT
60-79		CONTACT
80-109		STREET 1
110-139		STREET 2
140-164		CITY
165-166		STATE OR COUNRTY CODE
167-176		DOMESTIC ZIP OR FOREIGN POSTAL CODE
177-225		DEVICE NAME
226-231		DATE RECEIVED
232-237		DECISION DATE
238-239		DECISION
240-241		ADVISORY COMMITTEE
242-244		PRODUCT CODE
245-254		Contains either "SUMMARY" or "STATEMENT" SUMMARY indicates that a summary of safety and effectiveness information is available from FDA STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant
255-256		Contains the Advisory Committee Code under which the product was classified, based on the product code
257		Contains one of the following indicators: m = Summary only M = Summary/purged 510(k) t = Statement only T = Statement/purged 510(k) P = Purged, no summary or statement
258-268		Denotes the type of 510(k) submission: Traditional Special Abbreviated Evaluation of Automatic Class III Designation
269		Blank
270		Third Party Flag - Y or N - Indicates if the 510(k) was reviewed by a Third Party
271		Expedited Review Flag - Y, N or null - Indicates if the 510(k) was granted expedited review status.
272		"X" End of Record marker

510(k) DECISION CODES Substantially Equivalent Codes

KD	Substantially Equivalent - Kit with Drugs
PR	Substantially Equivalent - Proposed Recision
PT	Substantially Equivalent - Subject to Tracking & PMS
RN	Substantially Equivalent - Rescind Non-Substantial Equivalence
SA	Substantially Equivalent - Awaiting Device Approval
SD	Substantially Equivalent with Drug
SE	Substantially Equivalent
SF	Substantially Equivalent - Awaiting Future Policies
SI	Substantially Equivalent - Market after Inspection
SK	Substantially Equivalent - Kit
SN	Substantially Equivalent for Some Indications
SP	Substantially Equivalent - PostMarket Surveillance Required
ST	Substantially Equivalent - Subject to Tracking Reg.
SW	Substantially Equivalent - Awaiting Drug Approval

Non-Substantially Equivalent Codes

FB	Subject to 515(b) - Requires PMA
NE	Not Substantially Equivalent
SC	Not Substantially Equivalent - Cannot Market
SL	Not Substantially Equivalent - Improper Label
RE	Rescind Substantial Equivalence
UD	Unable to Determine Equivalence
UO	Unable to Determine Equivalence - Outstanding Drug Issue
UR	Not Substantially Equivalent - Unreliable Data
OD	Unable to Determine Equivalence - Outstanding Device Issue

Other Decision Codes

CR	Additional Information Requested; Applicant can not respond within 30 days
DB	Forwarded to Drugs/Biologics
DD	Deleted/Duplicate
DE	Deleted
DR	Drug (CDER) Review Required
EX	Exempted by Regulation
GP	General Purpose Article
K4	Closeout Letter Issued
NA	Not Actively Regulated
ND	Not a Device
NF	Not a Finished Product
NR	Not a Required Submission
PE	Preamendment Exempt
RC	Reconditioner/Remanufacturer
TR	Transitional Device
WD	Withdrawn by Applicant