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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 K852818
Device Name STERILE DISPOSABLE SYRINGES(2 PIECES)
Applicant
Fabersanitas, S.A.
Princesa
15-50004 Zaragoza-Spain,  ES
Applicant Contact JALON COROMIN
Correspondent
Fabersanitas, S.A.
Princesa
15-50004 Zaragoza-Spain,  ES
Correspondent Contact JALON COROMIN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/01/1985
Decision Date 07/29/1985
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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