FDA 510(k) Application Details - K140039

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K140039
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant AUROLAB
NO 1, SIVAGANGAI MAIN ROAD
VEERAPANJAN
MADURAI, TAMILNADU 625020 IN
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Contact KRISHNA KUMAR.R
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 01/07/2014
Decision Date 09/15/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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