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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K880802
Device Name SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
Applicant
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact MARILYN WAXBERG
Correspondent
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact MARILYN WAXBERG
Regulation Number876.1500
Classification Product Code
FGB  
Date Received02/29/1988
Decision Date 05/26/1988
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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