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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K852817
Device Name STERILE, DISPOSABLE NEEDLE
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 Number878.4800
Classification Product Code
GAA  
Date Received07/01/1985
Decision Date 07/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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