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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K241168
Device Name System 83 Revolve Endoscope Washer/Disinfector
Applicant
Wassenburg Medical, Inc.
144 Railroad Dr.
Ivyland,  PA  18974
Applicant Contact Mario Infanti
Correspondent
Wassenburg Medical, Inc.
144 Railroad Dr.
Ivyland,  PA  18974
Correspondent Contact Mario Infanti
Regulation Number876.1500
Classification Product Code
FEB  
Date Received04/26/2024
Decision Date 12/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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