FDA 510(k) Application Details - K921498

Device Classification Name Stimulator, Nerve, Ac-Powered

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510(K) Number K921498
Device Name Stimulator, Nerve, Ac-Powered
Applicant VERMONT MEDICAL, INC.
INDUSTRIAL PARK
BELLOWS FALLS, VT US
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Contact PAMELA SOPCZYK
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Regulation Number 868.2775

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Classification Product Code BXM
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Date Received 03/31/1992
Decision Date 06/09/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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