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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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More FDA Info for this Product Code
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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