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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K061962
Device Name SURGI-CUF REUSABLE, RS SERIES
Applicant
Ethox International
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact JOHN RIGGI
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/12/2006
Decision Date 07/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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