The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey Reusable Aspiration-vac Probes With And Without Puncture Cannula (hereinafter Referred To As Aspiration-v).
| Device ID | K946380 |
| 510k Number | K946380 |
| Device Name: | NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Contact | Martine Schneider |
| Correspondent | Martine Schneider AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-07-06 |