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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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K030351
Device Name STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
Applicant
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Applicant Contact MARY ANN GREENAWALT
Correspondent
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Correspondent Contact MARY ANN GREENAWALT
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received02/03/2003
Decision Date 03/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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