Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
K-Number: K233954 · 2024-02-13
ApplicantB&E Korea Co., Ltd.
Decision Date2024-02-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu is a medical device manufactured by B&E Korea Co., Ltd.. It received FDA 510(k) clearance on 2024-02-13 under approval number K233954. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu?
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu is a medical device that received FDA 510(k) clearance on 2024-02-13. It is manufactured by B&E Korea Co., Ltd.. The 510(k) number is K233954.
When was Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu approved by the FDA?
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu received FDA 510(k) clearance on 2024-02-13, under approval number K233954.
What company makes Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu?
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu is manufactured by B&E Korea Co., Ltd..
What is the FDA product code for Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu?
The FDA product code for Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu is ELW.
Related Devices (Code: ELW)
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.