The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for St. Mark's Rectal Biopsy Forceps.
| Device ID | K822401 |
| 510k Number | K822401 |
| Device Name: | ST. MARK'S RECTAL BIOPSY FORCEPS |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-10 |
| Decision Date | 1982-08-27 |