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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K903440
Device Name VIVAMED FISTULA NEEDLE
Applicant
S.S. Ent.
S&S Associates
34 Ravenwood Dr.
Weston,  CT  06883
Applicant Contact KEVIN SZOGAS
Correspondent
S.S. Ent.
S&S Associates
34 Ravenwood Dr.
Weston,  CT  06883
Correspondent Contact KEVIN SZOGAS
Regulation Number876.5540
Classification Product Code
FIE  
Date Received07/31/1990
Decision Date 04/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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