FDA 510(k) Application Details - K994177

Device Classification Name Suture, Nonabsorbable, Silk

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510(K) Number K994177
Device Name Suture, Nonabsorbable, Silk
Applicant VISIONARY MEDICAL SUPPLIES, INC.
4740 CONNECTICUT AVE. N.W.
SUITE 708
WASHINGTON, DC 20008 US
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Contact JONATHAN GREEN
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Regulation Number 878.5030

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Classification Product Code GAP
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Date Received 12/10/1999
Decision Date 02/08/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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