The following data is part of a premarket notification filed by Zimmer Patient Care Division with the FDA for General Surgery Probe/general Surgery Probe W/distal Perforations.
| Device ID | K935709 |
| 510k Number | K935709 |
| Device Name: | GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ZIMMER PATIENT CARE DIVISION 200 WEST OHIO AVE. P.O.BOX 10 Dover, OH 44622 |
| Contact | Paula S Osorio |
| Correspondent | Paula S Osorio ZIMMER PATIENT CARE DIVISION 200 WEST OHIO AVE. P.O.BOX 10 Dover, OH 44622 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-01-31 |