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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 K944920
Device Name CG DISPOSABLE SYRINGE
Applicant
Fortunique Medical Products
28th Floor, Ubn Tower, # 10
Jalan P. Ramlee
Kuala Lumpur,  MY 50250
Applicant Contact CHARLES M HUBBS
Correspondent
Fortunique Medical Products
28th Floor, Ubn Tower, # 10
Jalan P. Ramlee
Kuala Lumpur,  MY 50250
Correspondent Contact CHARLES M HUBBS
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received10/06/1994
Decision Date 12/20/1994
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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