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FDA 510(k) Application Details - K965045
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K965045
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
Other 510(k) Applications for this Company
Contact
IVAN S PLACKO
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
12/17/1996
Decision Date
05/05/1997
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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