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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 K904388
Device Name POINTER F-3 TENS
Applicant
Oms Medical Supplies, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact THOMAS RIIHIMAKI
Correspondent
Oms Medical Supplies, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact THOMAS RIIHIMAKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/25/1990
Decision Date 06/04/1991
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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