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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 K002360
Device Name CLOUD CUFF
Applicant
Parts Port, Ltd.
1801 Walthall Creek Dr.
Colonial Heights,  VA  23834
Applicant Contact CATHY SEBASTIAN
Correspondent
Parts Port, Ltd.
1801 Walthall Creek Dr.
Colonial Heights,  VA  23834
Correspondent Contact CATHY SEBASTIAN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/03/2000
Decision Date 09/26/2000
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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