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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 K880980
Device Name SCHULDT* PC* - DUAL CHANNEL TENS
Applicant
Schuldt Laboratories, Inc.
P.O. Box 183, Station "A"
Kelowna, British Columbia
Canada,  CA V1Y 1P0
Applicant Contact GRABRECK, PHD
Correspondent
Schuldt Laboratories, Inc.
P.O. Box 183, Station "A"
Kelowna, British Columbia
Canada,  CA V1Y 1P0
Correspondent Contact GRABRECK, PHD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/08/1988
Decision Date 04/11/1988
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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