FDA 510(k) Application Details - K152432

Device Classification Name

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510(K) Number K152432
Device Name ActiPatch(R)
Applicant BIOELECTRONICS CORPORATION
4539 METROPOLITAN COURT
FREDERICK, MD 21704 US
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Contact ANDREW WHELAN
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Regulation Number

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Classification Product Code PQY
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Date Received 08/27/2015
Decision Date 02/03/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K152432


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