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FDA 510(k) Application Details - K083638
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K083638
Device Name
Laparoscope, General & Plastic Surgery
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Regulation Number
876.1500
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Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2008
Decision Date
12/23/2008
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
Y
Expedited Review
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