FDA 510(k) Application Details - K020007

Device Classification Name

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510(K) Number K020007
Device Name SAFYRE SLING SYSTEM
Applicant PROMEDON
7 MAIN ST.
ESSEX JUNCTION, VT 05452 US
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Contact DEBBIE IAMPIETRO
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Regulation Number

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Classification Product Code OTN
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Date Received 01/02/2002
Decision Date 03/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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