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FDA 510(k) Application Details - K141323
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K141323
Device Name
Laparoscope, General & Plastic Surgery
Applicant
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, MN 55114 US
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Contact
MARK JOB
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
05/20/2014
Decision Date
06/04/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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