FDA 510(k) Application Details - K965245

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K965245
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE, UT 84047-1048 US
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Contact JOHN W SMITH
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 12/31/1996
Decision Date 07/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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