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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K171336
Device Name Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Henke-Sass, Wolf GmbH
Keltenstrasse 1
tuttlingen,  DE 78532
Applicant Contact anna reifschneider
Henke-Sass, Wolf GmbH
Keltenstrasse 1
tuttlingen,  DE 78532
Correspondent Contact anna reifschneider
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received05/08/2017
Decision Date 12/07/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No