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FDA 510(k) Application Details - K140101
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K140101
Device Name
Laparoscope, General & Plastic Surgery
Applicant
ABMEDICA SAS
333 QUARRY ROAD
MILFORD, CT 06460 US
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Contact
DANIEL DONOVAN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
01/15/2014
Decision Date
07/10/2014
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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