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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 K072229
Device Name MONOSWIFT
Applicant
CP MEDICAL
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Applicant Contact BETSY CORTELLONI
Correspondent
CP MEDICAL
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Correspondent Contact BETSY CORTELLONI
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/10/2007
Decision Date 10/05/2007
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
Recalls CDRH Recalls
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