The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Finess I (dermatologic Application).
Device ID | K951032 |
510k Number | K951032 |
Device Name: | FINESS I (DERMATOLOGIC APPLICATION) |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Contact | John W Smith |
Correspondent | John W Smith UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-06 |
Decision Date | 1995-04-06 |