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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 K842888
Device Name DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
Applicant
CRYOMEDICS, INC.
500 BOSTWICK AVE.
BRIDGEPORT,  CT  06605
Applicant Contact RICHARD E FRANKO
Correspondent
CRYOMEDICS, INC.
500 BOSTWICK AVE.
BRIDGEPORT,  CT  06605
Correspondent Contact RICHARD E FRANKO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/23/1984
Decision Date 01/14/1985
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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