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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K893693
Device Name H.U. I.V. DROP COUNTER
Applicant
Li-Lien Corp.
C/O Tridec Corporation
1590 Old Oakland Rd. Suite B 109
San Jose,  CA  95131
Applicant Contact SIMON FUNG
Correspondent
Li-Lien Corp.
C/O Tridec Corporation
1590 Old Oakland Rd. Suite B 109
San Jose,  CA  95131
Correspondent Contact SIMON FUNG
Regulation Number880.2420
Classification Product Code
FLN  
Date Received05/16/1989
Decision Date 10/27/1989
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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