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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K010186
Device Name WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
Applicant
WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN,  NC  28704
Applicant Contact DAVID A YOUNG II
Correspondent
WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN,  NC  28704
Correspondent Contact DAVID A YOUNG II
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/22/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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