FDA 510(k) Application Details - K953205

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K953205
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant FISHER & PAYKEL HEALTHCARE, LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND NZ
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Contact CHRIS MANDER
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 05/30/1995
Decision Date 05/23/1996
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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