The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Tbd.
Device ID | K965245 |
510k Number | K965245 |
Device Name: | TBD |
Classification | Electrocautery, Gynecologic (and 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 | HGI |
CFR Regulation Number | 884.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-31 |
Decision Date | 1997-07-03 |
Summary: | summary |