FDA 510(k) Application Details - K120556

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K120556
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant RIVERPOINT MEDICAL
825 NE 25th Ave
Portland, OR 97232 US
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Contact DOUG ROWLEY
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 02/24/2012
Decision Date 05/23/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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