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FDA 510(k) Application Details - K060414
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K060414
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
KMI KOLSTER METHODS, INC.
3185 PALISADES DR.
CORONA, CA 92882 US
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Contact
JEFFREY A KOLSTER
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Regulation Number
878.5010
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Classification Product Code
GAW
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More FDA Info for this Product Code
Date Received
02/16/2006
Decision Date
10/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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