FDA 510(k) Application Details - K014273

Device Classification Name Stimulator, Electro-Acupuncture

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510(K) Number K014273
Device Name Stimulator, Electro-Acupuncture
Applicant S.H.P. INTL. PTY., LTD.
5/212 GLEN OSMOND RD.
FULLARTON, S.A. 5063 AU
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Contact E.D. RICHARDS
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Regulation Number 000.0000

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Classification Product Code BWK
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Date Received 12/27/2001
Decision Date 06/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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