FDA 510(k) Application Details - K111233

Device Classification Name

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510(K) Number K111233
Device Name SUPRIS RETROPUBIC SLING SYSTEM
Applicant COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS, MN 55411 US
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Contact TIM CRABTREE
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Regulation Number

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Classification Product Code OTN
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Date Received 05/02/2011
Decision Date 06/24/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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