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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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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