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FDA 510(k) Application Details - K080161
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K080161
Device Name
Laparoscope, General & Plastic Surgery
Applicant
PATTON SURGICAL CORP.
6300 BRIDGEPOINT PKWY.
BLDG. 2, STE. 420
AUSTIN, TX 78730 US
Other 510(k) Applications for this Company
Contact
MICHAEL PATTON
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/23/2008
Decision Date
05/29/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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