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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 K864561
Device Name DERATA MEDI-JECTOR IV
Applicant
Derata Corp.
6701 Pkwy. Cir. Suite 100
Minneapolis,  MN  55430
Applicant Contact KENNETH W DUNLAP
Correspondent
Derata Corp.
6701 Pkwy. Cir. Suite 100
Minneapolis,  MN  55430
Correspondent Contact KENNETH W DUNLAP
Regulation Number880.5430
Classification Product Code
KZE  
Date Received11/19/1986
Decision Date 02/19/1987
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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