Decision Date1984-04-05
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
HARVARD ANTI-REFLUX Y-SET is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840760. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HARVARD ANTI-REFLUX Y-SET?
HARVARD ANTI-REFLUX Y-SET is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K840760.
When did HARVARD ANTI-REFLUX Y-SET receive FDA 510(k) clearance?
HARVARD ANTI-REFLUX Y-SET received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840760.
Who is the listed applicant for HARVARD ANTI-REFLUX Y-SET?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HARVARD ANTI-REFLUX Y-SET?
The FDA product code for HARVARD ANTI-REFLUX Y-SET is FPA.
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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.