The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for End-o-fog Endoscopic Fog Elimination System.
| Device ID | K943927 |
| 510k Number | K943927 |
| Device Name: | END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach, FL 33445 |
| Contact | Marian D Harding |
| Correspondent | Marian D Harding 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 | 1994-08-12 |
| Decision Date | 1994-09-16 |