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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K002190
Device Name POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
Applicant
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Applicant Contact PATRICK FERGUSON
Correspondent
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Correspondent Contact PATRICK FERGUSON
Regulation Number878.4493
Classification Product Code
GAM  
Date Received07/20/2000
Decision Date 08/10/2000
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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