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FDA 510(k) Application Details - K982853
Device Classification Name
Suture, Nonabsorbable, Silk
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510(K) Number
K982853
Device Name
Suture, Nonabsorbable, Silk
Applicant
DAVIS & GECK, INC.
444 MC DONNELL BLVD.
HAZELWOOD, MO 63042 US
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Contact
VANADA JOHNSON
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Regulation Number
878.5030
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Classification Product Code
GAP
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More FDA Info for this Product Code
Date Received
08/13/1998
Decision Date
04/30/1999
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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