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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 K831487
Device Name ELECTRONEURAL STIMULATOR 12
Applicant
MERIDIA 12 CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MERIDIA 12 CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/10/1983
Decision Date 10/28/1983
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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