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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 K030532
Device Name CPCA2000 COUNTERPULSATION SYSTEM
Applicant
Cpca2000, Inc.
6336 17th St. Cir. E.
Sarasota,  FL  34243
Applicant Contact ROD SHIPMAN
Correspondent
Cpca2000, Inc.
6336 17th St. Cir. E.
Sarasota,  FL  34243
Correspondent Contact ROD SHIPMAN
Regulation Number870.5225
Classification Product Code
DRN  
Date Received02/19/2003
Decision Date 03/14/2003
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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