FDA 510(k) Application Details - K051700

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K051700
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant MEDCHANNEL, LLC
55 WORCESTER STREET #3
BOSTON, MA 02118 US
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Contact FREDERICK TOBIA
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 06/24/2005
Decision Date 08/15/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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