FDA 510(k) Application Details - K041305

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K041305
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact MELISSA MURPHY
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 05/17/2004
Decision Date 06/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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