The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Finesse Iec/601.
Device ID | K941251 |
510k Number | K941251 |
Device Name: | FINESSE IEC/601 |
Classification | Electrocautery, Gynecologic (and Accessories) |
Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Contact | Ed Goodman |
Correspondent | Ed Goodman UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Product Code | HGI |
CFR Regulation Number | 884.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-15 |
Decision Date | 1994-12-12 |