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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 K844244
Device Name DERATA MEDI-JECTOR PRO
Applicant
Derata Corp.
7380 32nd. Ave. N.
Minneapolis,  MN  55427
Applicant Contact KENNETH W DUNLAP
Correspondent
Derata Corp.
7380 32nd. Ave. N.
Minneapolis,  MN  55427
Correspondent Contact KENNETH W DUNLAP
Regulation Number880.5430
Classification Product Code
KZE  
Date Received11/01/1984
Decision Date 07/05/1985
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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