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FDA 510(k)

OREX(R) O.R EQUIPMENT DRAPES

K-Number: K945755 · 1995-05-25

ApplicantThantex Specialties, Inc.
Decision Date1995-05-25
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OREX(R) O.R EQUIPMENT DRAPES 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 1995-05-25 under 510(k) number K945755. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OREX(R) O.R EQUIPMENT DRAPES?

OREX(R) O.R EQUIPMENT DRAPES is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K945755.

When did OREX(R) O.R EQUIPMENT DRAPES receive FDA 510(k) clearance?

OREX(R) O.R EQUIPMENT DRAPES received FDA 510(k) clearance on 1995-05-25, under 510(k) number K945755.

Who is the listed applicant for OREX(R) O.R EQUIPMENT DRAPES?

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(R) O.R EQUIPMENT DRAPES?

The FDA product code for OREX(R) O.R EQUIPMENT DRAPES is KKX.

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Other records listing Thantex Specialties, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970547ISOLYSER SDS SHARPS CONTAINERK961083OREX SURGEON'S VESTK942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945223OREX ISOLATION GOWNK944859OREX SURGICAL DRAPES

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Related Devices (Code: KKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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