FDA 510(k) Application Details - K133906

Device Classification Name

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510(K) Number K133906
Device Name C-JAWS CERVICAL COMPRESSIVE STAPLE
Applicant MEDICREA INTERNATIONAL
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004 US
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Contact JOHN J SMITH
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Regulation Number

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Classification Product Code PHQ
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Date Received 12/23/2013
Decision Date 07/24/2014
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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