SoClean 3+— 510(k) K243815

Substantially Equivalent

Soclean, Inc.

FDA 510(k) clearance K243815 for SoClean 3+, Substantially Equivalent on 2025-10-10. Applicant: Soclean, Inc.. Device class: 2.

Clearance details

Applicant
Soclean, Inc.
Product code
Code QXQ
Device class
Class 2
Regulation
21 CFR 880.6993
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Peterborough, NH, US
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