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FDA 510(k)

OREX ISOLATION GOWN

K-Number: K945223 · 1995-04-25

ApplicantThantex Specialties, Inc.
Decision Date1995-04-25
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OREX ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Thantex Specialties, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K945223. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREX ISOLATION GOWN?

OREX ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K945223.

When did OREX ISOLATION GOWN receive FDA 510(k) clearance?

OREX ISOLATION GOWN received FDA 510(k) clearance on 1995-04-25, under 510(k) number K945223.

Who is the listed applicant for OREX ISOLATION GOWN?

The FDA 510(k) record lists Thantex Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OREX ISOLATION GOWN?

The FDA product code for OREX ISOLATION GOWN is FYC.

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Other records listing Thantex Specialties, Inc. 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.

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