FDA 510(k) Application Details - K120814

Device Classification Name

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510(K) Number K120814
Device Name PADLOCK CLIP-12
Applicant APONOS MEDICAL CORP.
16 HILLSIDE RD.
KINGSTON, NH 03848 US
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Contact JOHN FEE
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Regulation Number

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Classification Product Code PKL
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Date Received 03/19/2012
Decision Date 09/06/2012
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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