FDA 510(k) Application Details - K052373

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K052373
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant QUILL MEDICAL, INC.
2505 MERIDIAN PARKWAY
SUITE 150
RESEARCH TRIANGLE PARK, NC 27713 US
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Contact LOIS V SMART
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 08/30/2005
Decision Date 09/26/2005
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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