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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 K853416
Device Name MES-TENS(TENS)
Applicant
ORIENTAL MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Applicant Contact THOMAS RIIHIMAKI
Correspondent
ORIENTAL MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Correspondent Contact THOMAS RIIHIMAKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/14/1985
Decision Date 11/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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