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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 K161165
Device Name Next Science Irrigation Solution
Applicant
Next Science, LLC
8130 Baymeadows Way W., Suite 200
Jacksonville,  FL  33256
Applicant Contact MATTHEW MYNTTI
Correspondent
Next Science, LLC
8130 Baymeadows Way W., Suite 200
Jacksonville,  FL  33256
Correspondent Contact MATTHEW MYNTTI
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received04/25/2016
Decision Date 09/07/2016
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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