The following data is part of a premarket notification filed by Sunkey Medical Manufacturing, Inc. with the FDA for Aaron C Size(tm) High Temperature Cautery.
| Device ID | K870397 |
| 510k Number | K870397 |
| Device Name: | AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUNKEY MEDICAL MANUFACTURING, INC. P.O. BOX 17326 AIRPORT STATION Clearwater, FL 33520 |
| Contact | Robert Saron |
| Correspondent | Robert Saron SUNKEY MEDICAL MANUFACTURING, INC. P.O. BOX 17326 AIRPORT STATION Clearwater, FL 33520 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-02 |
| Decision Date | 1987-03-18 |