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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 K192349
Device Name Bactisure Wound Lavage
Applicant
Next Science, LLC
10550 Deerwood Park Blvd., Suite 300
Jacksonsonville,  FL  32256
Applicant Contact Jeanne Lee
Correspondent
Next Science, LLC
10550 Deerwood Park Blvd., Suite 300
Jacksonsonville,  FL  32256
Correspondent Contact Jeanne Lee
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received08/29/2019
Decision Date 01/23/2020
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 Yes
Predetermined Change
Control Plan Authorized		 No
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