FDA 510(k) Application Details - K070882

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K070882
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact JEFF SEMONE
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 03/30/2007
Decision Date 07/20/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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