FDA 510(k) K191057, Park's Pectus System, by Tdm Co., Ltd.
FDA 510(k) K191057, Park's Pectus System, by Tdm Co., Ltd.
Device Classification Name: Plate, Fixation, Bone
510(k) Number: K191057
Device Name: Park's Pectus System
Applicant: Tdm Co., Ltd.
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 04/22/2019
Decision Date: 03/19/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 1,198
Fully redacted pages: 887
Content pages: 311
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details