The following data is part of a premarket notification filed by Keller Instruments, Inc. with the FDA for Tip Off Forceps.
| Device ID | K854541 |
| 510k Number | K854541 |
| Device Name: | TIP OFF FORCEPS |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | KELLER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene Vanarsdale |
| Correspondent | Eugene Vanarsdale KELLER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1985-12-17 |