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FDA 510(k) Application Details - K132809
Device Classification Name
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510(K) Number
K132809
Device Name
INSTINCT ENDOSCOPIC HEMOCLIP
Applicant
WILSON-COOK MEDICAL INC.
4900 Bethania Station Rd
Winston Salem, NC 27105 US
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Contact
SCOTTIE FARIOLE
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Regulation Number
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Classification Product Code
PKL
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Date Received
09/09/2013
Decision Date
10/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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