The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Electrosurgical Cut & Coagulation Device & Access.
| Device ID | K912337 |
| 510k Number | K912337 |
| Device Name: | ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Contact | Drew D Weaver |
| Correspondent | Drew D Weaver MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-08-16 |