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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 K905367
Device Name E-20 RAPID CUFF INFLATOR
Applicant
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Applicant Contact EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Correspondent Contact EUGENE HOKANSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/27/1990
Decision Date 03/06/1991
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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