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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 K003369
Device Name LIFECARE COMPACT TENS DEVICE
Applicant
LIFECARE LTD.
BEIT HAPA'AMON (BOX 124)
20 HATA'AS ST.,
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
LIFECARE LTD.
BEIT HAPA'AMON (BOX 124)
20 HATA'AS ST.,
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/30/2000
Decision Date 03/08/2001
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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