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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 K902482
Device Name VITALMIX (SET & BAG)
Applicant
Pacific Device, Inc.
8572 Spectrum Ln.
San Diego,  CA  92121
Applicant Contact MIKE SHANNON
Correspondent
Pacific Device, Inc.
8572 Spectrum Ln.
San Diego,  CA  92121
Correspondent Contact MIKE SHANNON
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/04/1990
Decision Date 07/02/1990
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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