FDA 510(k) Application Details - K102225

Device Classification Name Devices, Breath Trapping, Alcohol

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510(K) Number K102225
Device Name Devices, Breath Trapping, Alcohol
Applicant ALCOPRO, INC.
1560 E. EDINGER AVENUE,
SUITE B
SANTA ANA, CA 92705 US
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Contact PERRY RUCKER
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Regulation Number 862.3050

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Classification Product Code DJZ
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Date Received 08/09/2010
Decision Date 04/06/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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