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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K030786
Device Name MONO-SWIFT
Applicant
Cp Medical
836 NE 24th Ave.
Portland,  OR  97232
Applicant Contact MARY ANN GREENAWALT
Correspondent
Cp Medical
836 NE 24th Ave.
Portland,  OR  97232
Correspondent Contact MARY ANN GREENAWALT
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/12/2003
Decision Date 05/06/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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