FDA 510(k)

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

K-Number: K200968 · 2020-12-28

Decision Date2020-12-28

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is the device name listed in this FDA 510(k) record. The listed applicant is Insung Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200968. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Insung Medical Co., Ltd.. The 510(k) number is K200968.

When did ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R receive FDA 510(k) clearance?

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200968.

Who is the listed applicant for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

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

What is the FDA product code for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

The FDA product code for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is CBI.

Related Devices (Code: CBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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