FDA 510(k) Application Details - K961645

Device Classification Name Device, Biofeedback

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510(K) Number K961645
Device Name Device, Biofeedback
Applicant LEXICOR MEDICAL TECHNOLOGY, INC.
5589 ARAPAHOE AVE., #206
BOULDER, CO 80303 US
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Contact MICHAEL M SHUPE
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 04/29/1996
Decision Date 10/31/1996
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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