The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey(tm) Reusable Aspiration-vac(tm) Probes With And Without Puncture Cannula.
| Device ID | K946089 |
| 510k Number | K946089 |
| Device Name: | NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741077128 | K946089 | 000 |