The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey Electrosurgical Hand Control Attachments, Pencil-grip Handles & Trumpet Valve W/cutting & Coagulation Hans.
| Device ID | K952070 |
| 510k Number | K952070 |
| Device Name: | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Contact | Martine D Scheider |
| Correspondent | Martine D Scheider AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1995-07-26 |