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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 K890155
Device Name MDP DISPOSABLE SYRINGE
Applicant
Mediplas Marketing
254 Jln Mahkota, Taman,
Maluri, Cheras
Kuala Lumpur,  MY 55100
Correspondent
Mediplas Marketing
254 Jln Mahkota, Taman,
Maluri, Cheras
Kuala Lumpur,  MY 55100
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/17/1989
Decision Date 02/24/1989
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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