FDA 510(k) Application Details - K150518

Device Classification Name Block, Bite

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510(K) Number K150518
Device Name Block, Bite
Applicant DUPACO INC.
4144 AVENIDA DE LA PLATA
OCEANSIDE, CA 92056 US
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Contact AN VU
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Regulation Number 882.5070

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Classification Product Code JXL
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Date Received 03/02/2015
Decision Date 06/29/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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