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FDA 510(k) Application Details - K955031
Device Classification Name
Stimulator, Nerve, Peripheral, Electric
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510(K) Number
K955031
Device Name
Stimulator, Nerve, Peripheral, Electric
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON, TX 77236-6221 US
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Contact
ALFRED C COATS
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Regulation Number
868.2775
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Classification Product Code
KOI
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More FDA Info for this Product Code
Date Received
11/02/1995
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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