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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K203446
Device Name TorrentX Wound Wash
Applicant
Next Science, LLC
10550 Deerwood Park Blvd., Suite 300
Jacksonsonville,  FL  32256
Applicant Contact Courtney Narain
Correspondent
Next Science, LLC
10550 Deerwood Park Blvd., Suite 300
Jacksonsonville,  FL  32256
Correspondent Contact Courtney Narain
Classification Product Code
FRO  
Date Received11/23/2020
Decision Date 09/23/2021
Decision Substantially Equivalent (SESE)
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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