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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 K882401
Device Name STONY BROOK MODEL EECP-MC1
Applicant
Stony Brook Trading and Development Corp.
25 Asharoken Ave.
Northport,  NY  11766
Applicant Contact HUI, PHD
Correspondent
Stony Brook Trading and Development Corp.
25 Asharoken Ave.
Northport,  NY  11766
Correspondent Contact HUI, PHD
Regulation Number870.5225
Classification Product Code
DRN  
Date Received06/10/1988
Decision Date 03/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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