Decision Date1992-12-03
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
CMI STOMA COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Community Medical Center. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K925249. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CMI STOMA COVERS?
CMI STOMA COVERS is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Community Medical Center. The 510(k) number is K925249.
When did CMI STOMA COVERS receive FDA 510(k) clearance?
CMI STOMA COVERS received FDA 510(k) clearance on 1992-12-03, under 510(k) number K925249.
Who is the listed applicant for CMI STOMA COVERS?
The FDA 510(k) record lists Community Medical Center as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CMI STOMA COVERS?
The FDA product code for CMI STOMA COVERS is BTO.
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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.