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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K014273
Device Name ACUSTIM
Applicant
S.H.P. Intl. Pty., Ltd.
5/212 Glen Osmond Rd.
Fullarton, S.A.,  AU 5063
Applicant Contact E.D. RICHARDS
Correspondent
S.H.P. Intl. Pty., Ltd.
5/212 Glen Osmond Rd.
Fullarton, S.A.,  AU 5063
Correspondent Contact E.D. RICHARDS
Classification Product Code
BWK  
Date Received12/27/2001
Decision Date 06/12/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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