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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 K910903
Device Name INFLATE-A-CUFF #7014
Applicant
Pa Medical Corp.
1512 Nashville Highway
P.O. Box 1286
Columbia,  TN  38401
Applicant Contact BAILEY VAUGHN
Correspondent
Pa Medical Corp.
1512 Nashville Highway
P.O. Box 1286
Columbia,  TN  38401
Correspondent Contact BAILEY VAUGHN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/05/1991
Decision Date 05/08/1991
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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