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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K210987
Device Name IRRIGO Wound Wash Jet System
Applicant
Inopro, Inc.
800 Rue Sud Porte A
Cowansville,  CA J2K 2Y3
Applicant Contact Alain Lefebvre
Correspondent
Inopro, Inc.
800 Rue Sud Porte A
Cowansville,  CA J2K 2Y3
Correspondent Contact Alain Lefebvre
Regulation Number880.5475
Classification Product Code
FQH  
Date Received04/01/2021
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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