Fassier-Duval Telescopic IM System
K-Number: K211292 · 2021-05-26
ApplicantPega Medical, Inc.
Decision Date2021-05-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fassier-Duval Telescopic IM System is a medical device manufactured by Pega Medical, Inc.. It received FDA 510(k) clearance on 2021-05-26 under approval number K211292. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fassier-Duval Telescopic IM System?
Fassier-Duval Telescopic IM System is a medical device that received FDA 510(k) clearance on 2021-05-26. It is manufactured by Pega Medical, Inc.. The 510(k) number is K211292.
When was Fassier-Duval Telescopic IM System approved by the FDA?
Fassier-Duval Telescopic IM System received FDA 510(k) clearance on 2021-05-26, under approval number K211292.
What company makes Fassier-Duval Telescopic IM System?
Fassier-Duval Telescopic IM System is manufactured by Pega Medical, Inc..
What is the FDA product code for Fassier-Duval Telescopic IM System?
The FDA product code for Fassier-Duval Telescopic IM System is HSB.
Related Clinical Trials
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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.