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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 K852267
Device Name ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES
Applicant
Axelgaard Mfg. Co., Ltd.
2302 Martin St.
Suite 320
Irvine,  CA  92715
Applicant Contact WALTER A HACKLER
Correspondent
Axelgaard Mfg. Co., Ltd.
2302 Martin St.
Suite 320
Irvine,  CA  92715
Correspondent Contact WALTER A HACKLER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/28/1985
Decision Date 06/18/1985
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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