FDA 510(k) Application Details - K070243

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K070243
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant VISIONARY MEDICAL SUPPLIES, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 01/25/2007
Decision Date 04/17/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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