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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K822378
Device Name TENS ELECTRODE
Applicant
Franklin Sales & Mfg. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Franklin Sales & Mfg. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/06/1982
Decision Date 08/24/1982
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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