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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K032767
Device Name LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
Applicant
LILY MEDICAL SUPPLIES CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
LILY MEDICAL SUPPLIES CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/05/2003
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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