FDA 510(k) Application Details - K203226

Device Classification Name Endoscope, Rigid

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510(K) Number K203226
Device Name Endoscope, Rigid
Applicant Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, IL 60061 US
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Contact Michael Loiterman
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Regulation Number 876.1500

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Classification Product Code GCM
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Date Received 11/02/2020
Decision Date 05/14/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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