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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 K954282
Device Name ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG
Applicant
Statcorp, Inc.
1200 Columbia Ave.
P.O. Box 1225
Franklin,  TN  37065
Applicant Contact JAMES M SHEPHERD
Correspondent
Statcorp, Inc.
1200 Columbia Ave.
P.O. Box 1225
Franklin,  TN  37065
Correspondent Contact JAMES M SHEPHERD
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/13/1995
Decision Date 02/06/1996
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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