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FDA 510(k)

H-H CRUCIFORM-SLIT VALVE

K-Number: K853363 · 1985-09-03

ApplicantHolter-Hausner Intl.
Decision Date1985-09-03
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

H-H CRUCIFORM-SLIT VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1985-09-03 under 510(k) number K853363. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-H CRUCIFORM-SLIT VALVE?

H-H CRUCIFORM-SLIT VALVE is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853363.

When did H-H CRUCIFORM-SLIT VALVE receive FDA 510(k) clearance?

H-H CRUCIFORM-SLIT VALVE received FDA 510(k) clearance on 1985-09-03, under 510(k) number K853363.

Who is the listed applicant for H-H CRUCIFORM-SLIT VALVE?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H CRUCIFORM-SLIT VALVE?

The FDA product code for H-H CRUCIFORM-SLIT VALVE is JXG.

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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.

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