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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K862352
Device Name ACCULATOR 487E
Applicant
Accu Science Corp.
P.O. Box 6248
Anaheim,  CA  92806
Applicant Contact OLIVER P SHEEKS
Correspondent
Accu Science Corp.
P.O. Box 6248
Anaheim,  CA  92806
Correspondent Contact OLIVER P SHEEKS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/20/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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