FDA 510(k) Application Details - K954505

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K954505
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant LIFE-TECH INTL., INC.
10920 KINGHURST
HOUSTON, TX 77099 US
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Contact ANDREW C KYLE
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 09/28/1995
Decision Date 12/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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