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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion
510(k) Number K950419
Device Name THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
Applicant
IMED CORP.
9775 BUSINESSPARK AVE.
san diego,  CA  92131 -1699
Applicant Contact ahmad sajadi
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
san diego,  CA  92131 -1699
Correspondent Contact ahmad sajadi
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received01/31/1995
Decision Date 06/21/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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