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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, electrode
510(k) Number K070926
Device Name ELECTRODE/EXTENSION CABLES, MODELS ATAR
Applicant
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number890.1175
Classification Product Code
IKD  
Date Received04/03/2007
Decision Date 06/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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