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FDA 510(k) Application Details - K951343
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K951343
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact
BETTY M JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
884.1720
More FDA Info for this Regulation Number
Classification Product Code
HET
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/1995
Decision Date
04/11/1996
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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