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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K021517
Device Name ABP FOR WINDOWS
Applicant
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Applicant Contact MARK ROSOFF
Correspondent
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Correspondent Contact MARK ROSOFF
Regulation Number870.1110
Classification Product Code
DSK  
Date Received05/10/2002
Decision Date 07/24/2002
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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