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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 K873420
Device Name GLOBALCARE(TENS)
Applicant
OMS MEDICO, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Applicant Contact JAMES PAISNER
Correspondent
OMS MEDICO, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Correspondent Contact JAMES PAISNER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/26/1987
Decision Date 10/08/1987
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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