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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
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