The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey Laparoscopic Hand Instruments.
| Device ID | K950507 |
| 510k Number | K950507 |
| Device Name: | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Contact | Martine D Schneider |
| Correspondent | Martine D Schneider AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-03-06 |