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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 K832605
Device Name TRANCOJECT DISPOSABLE SYRINGES
Applicant
HUBORGA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HUBORGA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/03/1983
Decision Date 11/14/1983
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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