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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K972843
Device Name PROTOS BLOOD TRANSFUSION SET
Applicant
Globe Ent., Inc.
4930 Campbell Rd.
Houston,  TX  77041
Applicant Contact STEPHEN Y JAN
Correspondent
Globe Ent., Inc.
4930 Campbell Rd.
Houston,  TX  77041
Correspondent Contact STEPHEN Y JAN
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received08/01/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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