The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Electro Surgical Tip Cleaner.
| Device ID | K802605 |
| 510k Number | K802605 |
| Device Name: | ELECTRO SURGICAL TIP CLEANER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-21 |
| Decision Date | 1980-11-12 |