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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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