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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 K903394
Device Name GLOBALCARE MICRO 11 AND MICROCARE (TENS)
Applicant
Globalcare Intl., Inc.
220 Linden St.
Holyoke,  MA  01040
Applicant Contact JOHN DUNN
Correspondent
Globalcare Intl., Inc.
220 Linden St.
Holyoke,  MA  01040
Correspondent Contact JOHN DUNN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/27/1990
Decision Date 05/06/1991
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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