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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K033657
Device Name MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
Applicant
LIVING DATA TECHNOLOGIES CORPORATION
55 NORTHERN BLVD. SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
LIVING DATA TECHNOLOGIES CORPORATION
55 NORTHERN BLVD. SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.5225
Classification Product Code
DRN  
Date Received11/21/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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