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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 K940214
Device Name STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF
Applicant
Statcorp, Inc.
P.O. Box 1225
1200 Columbia Hwy.
Franklin,  TN  37065
Applicant Contact JAMES M SHEPHERD
Correspondent
Statcorp, Inc.
P.O. Box 1225
1200 Columbia Hwy.
Franklin,  TN  37065
Correspondent Contact JAMES M SHEPHERD
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received01/14/1994
Decision Date 02/22/1994
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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