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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K944320
Device Name VENTED/NON-VENTED GEMINI ADMINISTRATION SET
Original Applicant
IMED CORP.
9775 businesspark ave.
san diego,  CA  92131 -1699
Original Contact ahmad sajadi
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/29/1994
Decision Date 02/14/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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