- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.