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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 K863492
Device Name METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.
Applicant
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact BETTY A LOCK
Correspondent
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact BETTY A LOCK
Regulation Number876.4620
Classification Product Code
FAD  
Date Received09/09/1986
Decision Date 12/18/1986
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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