The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Cutting And Coagulation Devices And Accessories.
| Device ID | K921696 |
| 510k Number | K921696 |
| Device Name: | CUTTING AND COAGULATION DEVICES AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Stephen Tamsett |
| Correspondent | Stephen Tamsett AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-11-18 |