TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM

Endoscope, Rigid

Richard Wolf Medical Instruments Corporation

The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Telescope 0 O 10mm Wl 305mm / Telescope 30 O 10mm Wl 305mm / Telescope 50 O 10mm Wl 305mm, Telescope 0 O 10mm Wl 440mm / Telescope 30 O 10mm Wl 440mm / Telescope 50 O 10mm Wl 440mm.

Pre-market Notification Details

Device IDK203226
510k NumberK203226
Device Name:TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
ClassificationEndoscope, Rigid
Applicant Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills,  IL  60061
ContactMichael Loiterman
CorrespondentMichael Loiterman
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills,  IL  60061
Product CodeGCM  
Subsequent Product CodeGCJ
Subsequent Product CodeHET
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-05-14

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