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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stopcock, I.V. Set
510(k) Number K010217
Device Name 4 PORT, 4 WAY STOPCOCK
Applicant
George Loo, MD
9814 Curwood Pl.
Beverly Hills,  CA  90210
Applicant Contact GEORGE LOO
Correspondent
George Loo, MD
9814 Curwood Pl.
Beverly Hills,  CA  90210
Correspondent Contact GEORGE LOO
Regulation Number880.5440
Classification Product Code
FMG  
Date Received01/24/2001
Decision Date 03/18/2001
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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