FDA 510(k) Application Details - K111348

Device Classification Name Cord, Retraction

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510(K) Number K111348
Device Name Cord, Retraction
Applicant CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact JOHN DISCKO
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Regulation Number 000.0000

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Classification Product Code MVL
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Date Received 05/13/2011
Decision Date 07/22/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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