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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 K040286
Device Name ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
Applicant
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact EON VERRALL
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/06/2004
Decision Date 03/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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