WAVICIDE-OPA MEC Indicator— 510(k) K202565

Name: FDA 510(k) clearance K202565
Creator: U.S. Food and Drug Administration
Published: 2020-12-02

Substantially Equivalent

Serim Research Corporation

FDA 510(k) clearance K202565 for WAVICIDE-OPA MEC Indicator, Substantially Equivalent on 2020-12-02. Applicant: Serim Research Corporation. Device class: 2.

Clearance details

Applicant: Serim Research Corporation
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2020-09-04
Decision date: 2020-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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