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FDA 510(k) Application Details - K111529
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K111529
Device Name
Instrument, Biopsy
Applicant
INSERT MOLDING SOLUTIONS, INC
4325 SETTINGDOWN CIRCLE
SUITE 103
CUMMING, GA 30028 US
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Contact
PAUL HENDRIXSON
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2011
Decision Date
07/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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