FDA 510(k) Application Details - K955026

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K955026
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant DATEX MEDICAL INSTRUMENTATION, INC.
2 HIGHWOOD DR.
TEWKSBURY, MA 01876 US
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Contact JOEL KENT
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 11/02/1995
Decision Date 04/28/1997
Decision SESE - SUBST EQUIV
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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