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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K232329
Device Name Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
Applicant
Medivators (A Subsidiary of Steris Corporation)
3150 Pollok Dr.
Conroe,  TX  77303
Applicant Contact Nick Wang
Correspondent
Medivators (A Subsidiary of Steris Corporation)
3150 Pollok Dr.
Conroe,  TX  77303
Correspondent Contact Nick Wang
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Codes
FDF   FEQ   OCX  
Date Received08/03/2023
Decision Date 12/21/2023
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
Predetermined Change
Control Plan Authorized		 No
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