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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 K844988
Device Name ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
Applicant
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact FRANK P WILTON
Correspondent
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Correspondent Contact FRANK P WILTON
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/26/1984
Decision Date 04/04/1985
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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