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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 K853898
Device Name SKYLARK MODEL 1001 TENS DEVICE
Applicant
Peleg Intl. Co.
1435 St. Alexandre St. #1240
Montreal P.Q. H3a 2g4
Canada,  CA
Applicant Contact AMI PELEG
Correspondent
Peleg Intl. Co.
1435 St. Alexandre St. #1240
Montreal P.Q. H3a 2g4
Canada,  CA
Correspondent Contact AMI PELEG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/20/1985
Decision Date 06/18/1986
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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