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Next Science Irrigation Solution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161165

by Next Science LLC

Identifiers

510(k) Number
K161165 FDA 510(k)
FDA Product Code
FQH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5475 FDA 510(k)
Regulation Number
880.5475 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Next Science Irrigation Solution by Next Science LLC — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Next Science LLC
FDA Applicant
Next Science, LLC

Sources (1)

  • FDA 510(k) K161165 24 fields · synced Jun 18, 2026