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FDA 510(k)

BENCOX Delta Option Heads

K-Number: K223828 · 2023-03-16

ApplicantCorentec Co., Ltd.
Decision Date2023-03-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BENCOX Delta Option Heads is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K223828. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENCOX Delta Option Heads?

BENCOX Delta Option Heads is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K223828.

When did BENCOX Delta Option Heads receive FDA 510(k) clearance?

BENCOX Delta Option Heads received FDA 510(k) clearance on 2023-03-16, under 510(k) number K223828.

Who is the listed applicant for BENCOX Delta Option Heads?

The FDA 510(k) record lists Corentec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BENCOX Delta Option Heads?

The FDA product code for BENCOX Delta Option Heads is LZO.

Other records listing Corentec Co., Ltd. as applicant

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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.

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