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FDA 510(k) Application Details - K123728
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K123728
Device Name
Laparoscope, General & Plastic Surgery
Applicant
FLEXBAR MACHINE CORP.
30 NORTHPORT ROAD
SOUND BEACH, NY 11789 US
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Contact
STEPHEN T MLCOCH
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
12/04/2012
Decision Date
12/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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