FDA 510(k) Application Details - K991045

Device Classification Name Conditioner, Signal, Physiological

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510(K) Number K991045
Device Name Conditioner, Signal, Physiological
Applicant MINI-MITTER CO., INC.
PO BOX 3386
SUNRIVER, OR 97707 US
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Contact JACK E MCKENZIE
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Regulation Number 882.1845

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Classification Product Code GWK
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Date Received 03/29/1999
Decision Date 09/21/1999
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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