The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Biopsy Forceps.
| Device ID | K921401 |
| 510k Number | K921401 |
| Device Name: | BIOPSY FORCEPS |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Contact | Stuart J Lind |
| Correspondent | Stuart J Lind ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-10-21 |