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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 K032568
Device Name BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
Applicant
Med Textile, LLC
14300 Wood Duck Ln.
Colonial Heights,  VA  23834
Applicant Contact BRITTNEY GILL
Correspondent
Med Textile, LLC
14300 Wood Duck Ln.
Colonial Heights,  VA  23834
Correspondent Contact BRITTNEY GILL
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/20/2003
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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