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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 K872517
Device Name TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
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 Number870.2780
Classification Product Code
JOM  
Date Received06/24/1987
Decision Date 10/01/1987
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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