The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Unipolar Coagulator Probe System.
| Device ID | K911274 |
| 510k Number | K911274 |
| Device Name: | UNIPOLAR COAGULATOR PROBE SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 901 EAST SAMPLE ROAD, SUITE C Pompano Beach, FL 33064 |
| Contact | Dorsey Iii |
| Correspondent | Dorsey Iii AMERICAN SURGICAL INSTRUMENTS CORP. 901 EAST SAMPLE ROAD, SUITE C Pompano Beach, FL 33064 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1991-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741077289 | K911274 | 000 |