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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K222734
Device Name Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
Applicant
Diversatek Healthcare
102 E. Keefe Ave.
Milwaukee,  WI  53212
Applicant Contact Alyssa Roelli
Correspondent
Diversatek Healthcare
102 E. Keefe Ave.
Milwaukee,  WI  53212
Correspondent Contact Alyssa Roelli
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
FEQ  
Date Received09/09/2022
Decision Date 11/08/2022
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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