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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K001172
Device Name POLYESTER NONABSORBABLE SURGICAL SUTURES URP
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 Number878.5000
Classification Product Code
GAT  
Date Received04/11/2000
Decision Date 06/23/2000
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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