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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 K864984
Device Name ROBINJECT
Applicant
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Applicant Contact JEFFREY SHIDEMAN,PHD
Correspondent
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY SHIDEMAN,PHD
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/22/1986
Decision Date 06/29/1987
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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