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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 K902853
Device Name GRAVITY PLUS CONTROLLER/COMPOUNDER
Applicant
Fergy Corp.
Dba Pie
1300 E. Main St.
Grass Valley,  CA  95945
Applicant Contact DAVE STOKES
Correspondent
Fergy Corp.
Dba Pie
1300 E. Main St.
Grass Valley,  CA  95945
Correspondent Contact DAVE STOKES
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/29/1990
Decision Date 05/09/1991
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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