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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 K834044
Device Name MEDI-JECTOR II
Applicant
Derata Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Derata Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5430
Classification Product Code
KZE  
Date Received11/23/1983
Decision Date 03/06/1984
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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