FDA 510(k) Application Details - K051397

Device Classification Name Device, Acupressure

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510(K) Number K051397
Device Name Device, Acupressure
Applicant BIOBANDS DISTRIBUTORS, INC.
1050 CONNECTICUT AVENUE NW
WASHINGTON, DC 20036 US
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Contact JAMES H HARTTEN
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Regulation Number 000.0000

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Classification Product Code MVV
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Date Received 05/27/2005
Decision Date 09/16/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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