The following data is part of a premarket notification filed by Primed Instruments, Inc. with the FDA for Forceps, Biopsy, Gastrointestinal.
| Device ID | K934186 |
| 510k Number | K934186 |
| Device Name: | FORCEPS, BIOPSY, GASTROINTESTINAL |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | PRIMED INSTRUMENTS, INC. 17 OXENDEN CRESCENT ETOBICOKE, ONTARIO, CANADA M9c 4h3, CA |
| Contact | Jacek Krzyzanowski |
| Correspondent | Jacek Krzyzanowski PRIMED INSTRUMENTS, INC. 17 OXENDEN CRESCENT ETOBICOKE, ONTARIO, CANADA M9c 4h3, CA |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1993-12-14 |