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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Empty, For Collection & Processing Of Blood & Blood Components
510(k) Number K810500
Device Name BLOOD FREEZING BAG
Applicant
Delmed, Inc.
(Sent To Bureau Of Drugs)
Correspondent
Delmed, Inc.
(Sent To Bureau Of Drugs)
Regulation Number864.9100
Classification Product Code
KSR  
Date Received02/24/1981
Decision Date 09/23/1981
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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