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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 K043591
Device Name FEATHERLIFT EXTENDED APTOS THREAD
Applicant
KMI KOLSTER METHODS, INC.
3185 PALISADES DR.
CORONA,  CA  92882
Applicant Contact KEITH DAVIS
Correspondent
KMI KOLSTER METHODS, INC.
3185 PALISADES DR.
CORONA,  CA  92882
Correspondent Contact KEITH DAVIS
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/28/2004
Decision Date 03/04/2005
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
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