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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K001461
Device Name TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
Applicant
Biometrix , Ltd.
4 Kiryat Mada
P.O. Box 45057
Jerusalem,  IL 91450
Applicant Contact MIRIAM ABUTBUL
Correspondent
Biometrix , Ltd.
4 Kiryat Mada
P.O. Box 45057
Jerusalem,  IL 91450
Correspondent Contact MIRIAM ABUTBUL
Regulation Number880.5025
Classification Product Code
KPE  
Date Received05/10/2000
Decision Date 09/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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