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FDA 510(k) Application Details - K955073
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K955073
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
BETTY M JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
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More FDA Info for this Product Code
Date Received
11/06/1995
Decision Date
12/06/1996
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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