Decision Date1985-03-04
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TROGIDE is the device name listed in this FDA 510(k) record. The listed applicant is Carmel Medical Devices. It received FDA 510(k) clearance on 1985-03-04 under 510(k) number K844696. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TROGIDE?
TROGIDE is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Carmel Medical Devices. The 510(k) number is K844696.
When did TROGIDE receive FDA 510(k) clearance?
TROGIDE received FDA 510(k) clearance on 1985-03-04, under 510(k) number K844696.
Who is the listed applicant for TROGIDE?
The FDA 510(k) record lists Carmel Medical Devices as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TROGIDE?
The FDA product code for TROGIDE is BTR.
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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.