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FDA Device Info: List of Predicate Devices with Claimed Equivalence
FDA Device Info: List of Predicate Devices with Claimed Equivalence
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Predicate device(s) to which manufacturer of each 510k device claims equivalence: In the requested information, please include the 510k/PMA number of predicate device(s) and the manufacturer(s) of the predicate device(s) of each 510k cleared device. [REQ YEAR: 2022]
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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