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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K910768
Device Name SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
Applicant
SURGITEK MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact STEVE APERAVICH
Correspondent
SURGITEK MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact STEVE APERAVICH
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/22/1991
Decision Date 03/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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