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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 K851519
Device Name FORTUNA DISPOSABLE SYRINGES
Applicant
Impor-Tex, Intl., Inc.
P.O. Box 6054
Richardson,  TX  75083
Applicant Contact FRANK M SCHURGAST
Correspondent
Impor-Tex, Intl., Inc.
P.O. Box 6054
Richardson,  TX  75083
Correspondent Contact FRANK M SCHURGAST
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/15/1985
Decision Date 06/17/1985
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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