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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 K030587
Device Name EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
Applicant
S-Tct Health, Inc.
2020 Ponce De Leon Blvd., Suite 1101
Coral Gables,  FL  33134
Applicant Contact KATHERINE L GIANNAMORE
Correspondent
S-Tct Health, Inc.
2020 Ponce De Leon Blvd., Suite 1101
Coral Gables,  FL  33134
Correspondent Contact KATHERINE L GIANNAMORE
Regulation Number870.5225
Classification Product Code
DRN  
Date Received02/25/2003
Decision Date 05/30/2003
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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