The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Nezhat/dorsey Hydro Dissection Pump Ob-gyn Use.
| Device ID | K896118 |
| 510k Number | K896118 |
| Device Name: | NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 2550 M STREET, N.W. Washington, DC 20037 |
| Contact | Stuart M Pape |
| Correspondent | Stuart M Pape AMERICAN SURGICAL INSTRUMENTS CORP. 2550 M STREET, N.W. Washington, DC 20037 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-23 |
| Decision Date | 1990-03-28 |