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FDA 510(k)

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

K-Number: K003423 · 2001-02-22

ApplicantSt. Francis Medical Equipment Co., Ltd.
Decision Date2001-02-22
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 is the device name listed in this FDA 510(k) record. The listed applicant is St. Francis Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K003423. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055?

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is St. Francis Medical Equipment Co., Ltd.. The 510(k) number is K003423.

When did ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 receive FDA 510(k) clearance?

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 received FDA 510(k) clearance on 2001-02-22, under 510(k) number K003423.

Who is the listed applicant for ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055?

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

What is the FDA product code for ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055?

The FDA product code for ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 is FTD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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