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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Warming. Blood And Plasma
510(k) Number K790936
Device Name MODEL 114 TREONIC H150 HAEMOHEATER
Applicant
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9205
Classification Product Code
KZL  
Date Received05/18/1979
Decision Date 09/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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