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 |