FDA 510(k)

MON-A-THERM FOLEY KIT

K-Number: K923538 · 1993-05-27

Decision Date1993-05-27

Product CodeFCM

Advisory CommitteeGU

DecisionUnknown

Device Summary

MON-A-THERM FOLEY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K923538. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MON-A-THERM FOLEY KIT?

MON-A-THERM FOLEY KIT is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Mallinckrodt Medical. The 510(k) number is K923538.

When did MON-A-THERM FOLEY KIT receive FDA 510(k) clearance?

MON-A-THERM FOLEY KIT received FDA 510(k) clearance on 1993-05-27, under 510(k) number K923538.

Who is the listed applicant for MON-A-THERM FOLEY KIT?

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

What is the FDA product code for MON-A-THERM FOLEY KIT?

The FDA product code for MON-A-THERM FOLEY KIT is FCM.

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Other records listing Mallinckrodt Medical 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.