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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor, self-retaining
510(k) Number K870897
Device Name KODNER ANAL PERIONEAL RETRACTOR
Applicant
SUR-MED INSTRUMENTS, INC.
9422-24 GRAVOIS RD.
ST. LOUIS,  MO  63123
Applicant Contact CHRISTA K NAGEL
Correspondent
SUR-MED INSTRUMENTS, INC.
9422-24 GRAVOIS RD.
ST. LOUIS,  MO  63123
Correspondent Contact CHRISTA K NAGEL
Regulation Number876.4730
Classification Product Code
FFO  
Date Received03/05/1987
Decision Date 06/04/1987
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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