FDA 510(k) Application Details - K023710

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K023710
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND, OR 97232 US
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Contact MARY ANN GREENAWALT
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 11/04/2002
Decision Date 01/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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