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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 K012455
Device Name WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
Applicant
WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN,  NC  28704
Applicant Contact DAVID A YOUNG
Correspondent
WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN,  NC  28704
Correspondent Contact DAVID A YOUNG
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/01/2001
Decision Date 08/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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