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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 K842067
Device Name CALCULATING CUFF INFLATOR TD312
Applicant
D. E. Hokanson, Inc.
2450 Newport Way SE
Issaquah,  WA  98027
Applicant Contact EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
2450 Newport Way SE
Issaquah,  WA  98027
Correspondent Contact EUGENE HOKANSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/23/1984
Decision Date 03/01/1985
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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