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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Long Term Support Greater Than 6 Hours
510(k) Number K770720
Device Name TUBING PACK, EXTRACORPOREAL, H-3000
Applicant
William Harvey Life Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
William Harvey Life Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4100
Classification Product Code
BYS  
Date Received04/18/1977
Decision Date 08/04/1977
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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