FDA 510(k) Application Details - K050947

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K050947
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact SHARON L MURPHY
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 04/15/2005
Decision Date 06/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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