The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Electrosurgical Pencil.
Device ID | K904808 |
510k Number | K904808 |
Device Name: | ELECTROSURGICAL PENCIL |
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 | 1990-10-24 |
Decision Date | 1991-01-04 |