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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 K140874
Device Name GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
Applicant
Shanghai Goahui Rubber and Plastic Company
144 Researcg Dr.
Hampton,  VA  23666
Applicant Contact RHONDA ALEXANDER, MS, MPA
Correspondent
Shanghai Goahui Rubber and Plastic Company
144 Researcg Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA ALEXANDER, MS, MPA
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received04/04/2014
Decision Date 09/02/2014
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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