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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 K840497
Device Name OBSTETRIC PULSAR TWO CHANNEL TENS
Applicant
SPEMBLY MEDICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SPEMBLY MEDICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/06/1984
Decision Date 04/16/1984
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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