FDA 510(k) Application Details - K130631

Device Classification Name

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510(K) Number K130631
Device Name BUZZY
Applicant MMJ LABS, LLC
322 SUTHERLAND PLACE
ATLANTA, GA 30307 US
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Contact VALERIE STAFFEY
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Regulation Number

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Classification Product Code PHW
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Date Received 03/08/2013
Decision Date 08/13/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K130631


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