FDA 510(k) Application Details - K163676

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K163676
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SILHOUETTE LIFT, INC.
1 TECHNOLOGY DRIVE
SUITE F211
IRVINE, CA 92618 US
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Contact DOUG ABEL
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 12/27/2016
Decision Date 06/16/2017
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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