The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Foot Control Pencil.
Device ID | K926306 |
510k Number | K926306 |
Device Name: | FOOT CONTROL PENCIL |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
Contact | Drew W Weaver |
Correspondent | Drew W 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 | 1992-12-15 |
Decision Date | 1993-02-05 |