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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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More FDA Info for this Product Code
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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