FDA 510(k) Application Details - K002190

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K002190
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND, OR 97232 US
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Contact PATRICK FERGUSON
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 07/20/2000
Decision Date 08/10/2000
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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