FDA 510(k) Application Details - K030177

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide

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510(K) Number K030177
Device Name Suture, Nonabsorbable, Synthetic, Polyamide
Applicant SRI ORION PHARMACEUTICALS & SUTURES
9109 COPENHAVER DR.
POTOMAC, MD 20854 US
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Contact NORMAN F ESTRIN
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Regulation Number 878.5020

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Classification Product Code GAR
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Date Received 01/17/2003
Decision Date 07/21/2003
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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