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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K023707
Device Name A16 BLOOD FLOW MEASUREMENT SYSTEM
Applicant
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005 -1910
Applicant Contact D. EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005 -1910
Correspondent Contact D. EUGENE HOKANSON
Regulation Number870.2780
Classification Product Code
JOM  
Date Received11/04/2002
Decision Date 02/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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