The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Forceps, Biopsy(non Rigid).
| Device ID | K852120 |
| 510k Number | K852120 |
| Device Name: | FORCEPS, BIOPSY(NON RIGID) |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Contact | Jake(jacobus) Scholt |
| Correspondent | Jake(jacobus) Scholt SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-07-02 |