WAVICIDE-OPA MEC Indicator
K-Number: K202565 · 2020-12-02
ApplicantSerim Research Corporation
Decision Date2020-12-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
WAVICIDE-OPA MEC Indicator is a medical device manufactured by Serim Research Corporation. It received FDA 510(k) clearance on 2020-12-02 under approval number K202565. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WAVICIDE-OPA MEC Indicator?
WAVICIDE-OPA MEC Indicator is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by Serim Research Corporation. The 510(k) number is K202565.
When was WAVICIDE-OPA MEC Indicator approved by the FDA?
WAVICIDE-OPA MEC Indicator received FDA 510(k) clearance on 2020-12-02, under approval number K202565.
What company makes WAVICIDE-OPA MEC Indicator?
WAVICIDE-OPA MEC Indicator is manufactured by Serim Research Corporation.
What is the FDA product code for WAVICIDE-OPA MEC Indicator?
The FDA product code for WAVICIDE-OPA MEC Indicator is JOJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.