FDA 510(k) Application Details - K032901

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K032901
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact MELISSA MURPHY
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 09/17/2003
Decision Date 12/02/2003
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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