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Medical Devices
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List 1 – Critical and Semicritical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements that Now Require 510(k)s With Validation Data
From September 29, 2005, Federal Register Notice)
| 21 CFR No. | Classification Name | Product Code for Nonreprocessed Device | Product Code for Reprocessed Device | Product Code Name for Reprocessed Device |
|---|---|---|---|---|
| 868.6810 | Tracheobronchial Suction Catheter | BSY | NQV | Tracheobronchial Suction Catheter |
| 870.4500 | Cardiovascular Surgical Instruments | MWS | NQG | Noncompression Heart Stabilizer |
| 872.3240 | Dental Bur | Diamond Coated | NME | Dental Diamond Coated Bur |
| 872.4535 | Dental Diamond Instrument | DZP | NLD | Dental Diamond Instrument |
| 872.4730 | Dental Injection Needle | DZM | NMW | Dental Needle |
| 872.5410 | Orthodontic Appliance and Accessories | EJF | NQS | Orthodontic Metal Bracket |
| 874.4140 | Ear, Nose, and Throat Bur | Microdebrider | NLY | ENT High Speed Microdebrider |
| 874.4140 | Ear, Nose, and Throat Bur | Diamond Coated | NLZ | ENT Diamond Coated Bur |
| 874.4420 | Ear, Nose, Throat Manual Surgical | KAB, KBG, KCI | NLB | Laryngeal, Sinus, Tracheal Trocar |
| 876.1075 | Gastroenterology- Urology Biopsy Instrument | FCL | NON | Nonelectric Biopsy Forceps |
| 876.4680 | Ureteral Stone Dislodger | FGO, FFL | NQT, NQU | Flexible and Basket Stone Dislodger |
| 878.4200 | Introduction/Drainage Catheter and Accessories | GCB | NMT | Catheter Needle |
| 878.4800 | Manual Surgical Instrument | MJG | NNA | Percutaneous Biopsy Device |
| 878.4800 | Manual Surgical Instrument | FHR | NMU | Gastro-Urology Needle |
| 878.4800 | Manual Surgical Instrument for . . . | DWO | NLK | Cardiovascular Biopsy Needle |
| 878.4800 | Manual Surgical Instrument for . . . | GAA | NNC | Aspiration and Injection Needle |
| 882.4190 | Forming/Cutting Clip Instrument | HBS | NMN | Forming/Cutting Clip Instrument |
| 884.1730 | Laparoscopic Insufflator, . . . | HIF | NMI | Laparoscopic Insufflator and Accessories |
| 884.4530 | OB/GYN Specialized Manual Insrument | HFB | NMG | Gynecological Biopsy Forceps |
| 886.4350 | Manual Ophthalmic Surgical Instrument | HNN | NLA | Ophthalmic Knife |
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