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FDA 510(k) Application Details - K962863
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K962863
Device Name
Insufflator, Laparoscopic
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact
RENATE M MACLAREN
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/1996
Decision Date
11/19/1996
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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