FDA 510(k) Application Details - K070673

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K070673
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact ELIZABETH LANDON
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 03/12/2007
Decision Date 04/02/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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