FDA 510(k) Application Details - K021033

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K021033
Device Name Stimulator, Nerve, Battery-Powered
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact SHERI L MUSGNUNG
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 03/29/2002
Decision Date 03/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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