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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K921031
Device Name EDGE MEDICAL DISPENSING PIN
Applicant
Edgewater Medical Center
9814 Curwood Pl.
Beverly Hills,  CA  90210
Applicant Contact GEORGE LOO
Correspondent
Edgewater Medical Center
9814 Curwood Pl.
Beverly Hills,  CA  90210
Correspondent Contact GEORGE LOO
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/03/1992
Decision Date 10/19/1992
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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