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FDA 510(k) Application Details - K955756
Device Classification Name
Electrocautery, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K955756
Device Name
Electrocautery, Gynecologic (And Accessories)
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact
RENATE A MACLAREN
Other 510(k) Applications for this Contact
Regulation Number
884.4120
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Classification Product Code
HGI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/1995
Decision Date
11/26/1996
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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