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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K920039
Device Name MEDIJECT DISPOSABLE SYRINGES
Applicant
P.T. Igar Jaya
3220 Producer Way
Pomona,  CA  91768
Applicant Contact DICK S LIEM
Correspondent
P.T. Igar Jaya
3220 Producer Way
Pomona,  CA  91768
Correspondent Contact DICK S LIEM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/06/1992
Decision Date 02/09/1994
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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