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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, polypropylene
510(k) Number K060414
Device Name KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
Applicant
KMI KOLSTER METHODS, INC.
3185 PALISADES DR.
CORONA,  CA  92882
Applicant Contact JEFFREY A KOLSTER
Correspondent
KMI KOLSTER METHODS, INC.
3185 PALISADES DR.
CORONA,  CA  92882
Correspondent Contact JEFFREY A KOLSTER
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
GAM  
Date Received02/16/2006
Decision Date 10/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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