The following data is part of a premarket notification filed by Medicon Instruments, Inc. with the FDA for Medicon Instruments Unipolar Coagulation Electrodes.
| Device ID | K936249 |
| 510k Number | K936249 |
| Device Name: | MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-07-21 |