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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K965245
Device Name TBD
Applicant
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Applicant Contact JOHN W SMITH
Correspondent
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Correspondent Contact JOHN W SMITH
Regulation Number884.4120
Classification Product Code
HGI  
Date Received12/31/1996
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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