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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 K853031
Device Name JECT-AID
Applicant
Autoject Systems, Inc.
1001 E. Morton Pl.
Hemet,  CA  92343
Applicant Contact WILIIAM B SCHMITZ
Correspondent
Autoject Systems, Inc.
1001 E. Morton Pl.
Hemet,  CA  92343
Correspondent Contact WILIIAM B SCHMITZ
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/18/1985
Decision Date 01/01/1986
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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