The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Manual Surgical Instrments For Laparoscopy.
| Device ID | K915372 |
| 510k Number | K915372 |
| Device Name: | MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1992-04-06 |