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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 K894842
Device Name IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
Applicant
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Applicant Contact JARBOE, PHD
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Correspondent Contact JARBOE, PHD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/31/1989
Decision Date 09/12/1989
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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