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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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