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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K873455
Device Name S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
Applicant
Dravon Medical, Inc.
P.O. Box 69, 11465 SE
Hwy. 212
Clackamas,  OR  97015
Applicant Contact MADALYN C DUNCAN
Correspondent
Dravon Medical, Inc.
P.O. Box 69, 11465 SE
Hwy. 212
Clackamas,  OR  97015
Correspondent Contact MADALYN C DUNCAN
Regulation Number876.5820
Classification Product Code
FJK  
Date Received08/28/1987
Decision Date 09/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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