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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K905289
Device Name SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
Applicant
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact STEVE APERAVICH
Correspondent
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact STEVE APERAVICH
Regulation Number876.4620
Classification Product Code
FAD  
Date Received11/26/1990
Decision Date 03/13/1991
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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