Thermoforming Sheet Materials
K-Number: K200125 · 2020-10-28
ApplicantErkodent Erich Kopp GmbH
Decision Date2020-10-28
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
Thermoforming Sheet Materials is a medical device manufactured by Erkodent Erich Kopp GmbH. It received FDA 510(k) clearance on 2020-10-28 under approval number K200125. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Thermoforming Sheet Materials?
Thermoforming Sheet Materials is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Erkodent Erich Kopp GmbH. The 510(k) number is K200125.
When was Thermoforming Sheet Materials approved by the FDA?
Thermoforming Sheet Materials received FDA 510(k) clearance on 2020-10-28, under approval number K200125.
What company makes Thermoforming Sheet Materials?
Thermoforming Sheet Materials is manufactured by Erkodent Erich Kopp GmbH.
What is the FDA product code for Thermoforming Sheet Materials?
The FDA product code for Thermoforming Sheet Materials is MQC.
Related Devices (Code: MQC)
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.