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FDA 510(k)

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS

K-Number: K942200 · 1995-08-07

ApplicantThantex Specialties, Inc.
Decision Date1995-08-07
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS 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 1995-08-07 under 510(k) number K942200. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS?

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K942200.

When did ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS receive FDA 510(k) clearance?

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS received FDA 510(k) clearance on 1995-08-07, under 510(k) number K942200.

Who is the listed applicant for ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS?

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 ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS?

The FDA product code for ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS is LYU.

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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 VESTK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945755OREX(R) O.R EQUIPMENT DRAPESK945223OREX ISOLATION GOWNK944859OREX SURGICAL DRAPES

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Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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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