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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K884293
Device Name J-TIP INJECTOR SYSTEM
Applicant
California Medical Innovations, Inc.
24121 Big Timber St.
Lake Forest,  CA  92630
Applicant Contact BOOHER, PHD
Correspondent
California Medical Innovations, Inc.
24121 Big Timber St.
Lake Forest,  CA  92630
Correspondent Contact BOOHER, PHD
Regulation Number880.5430
Classification Product Code
KZE  
Date Received10/12/1988
Decision Date 01/09/1989
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
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