Park's Pectus System
K-Number: K191057 · 2020-03-19
ApplicantTdm Co., Ltd.
Decision Date2020-03-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Park's Pectus System is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2020-03-19 under approval number K191057. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Park's Pectus System?
Park's Pectus System is a medical device that received FDA 510(k) clearance on 2020-03-19. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K191057.
When was Park's Pectus System approved by the FDA?
Park's Pectus System received FDA 510(k) clearance on 2020-03-19, under approval number K191057.
What company makes Park's Pectus System?
Park's Pectus System is manufactured by Tdm Co., Ltd..
What is the FDA product code for Park's Pectus System?
The FDA product code for Park's Pectus System is HRS.
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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.