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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K062401
Device Name MODIFICATION TO LUCAS
Applicant
Jolife AB
555 13th St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Jolife AB
555 13th St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number870.5200
Classification Product Code
DRM  
Date Received08/16/2006
Decision Date 09/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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