The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Forceps, Biopsy, Non-electric.
| Device ID | K952863 |
| 510k Number | K952863 |
| Device Name: | FORCEPS, BIOPSY, NON-ELECTRIC |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | ANNEX MEDICAL, INC. 7098 SHADY OAK RD. Eden Prairie, MN 55344 |
| Contact | Eugene C Karels |
| Correspondent | Eugene C Karels ANNEX MEDICAL, INC. 7098 SHADY OAK RD. Eden Prairie, MN 55344 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-22 |
| Decision Date | 1995-07-19 |