The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Nezhat/dorsey Hydro Dissection Pump & Accessories.
| Device ID | K913944 |
| 510k Number | K913944 |
| Device Name: | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Contact | James H Dorsey |
| Correspondent | James H Dorsey AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-04 |
| Decision Date | 1992-03-09 |