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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 K974080
Device Name CRITIKON SOFT BLOOD PRESSURE CUFF
Applicant
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Applicant Contact DARLENE T KORAB
Correspondent
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Correspondent Contact DARLENE T KORAB
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/29/1997
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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