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FDA 510(k)

QUALTEX SURGICAL DRAPE

K-Number: K910495 · 1991-02-19

ApplicantDeroyal Industries, Inc.
Decision Date1991-02-19
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K910495. 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 QUALTEX SURGICAL DRAPE?

QUALTEX SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K910495.

When did QUALTEX SURGICAL DRAPE receive FDA 510(k) clearance?

QUALTEX SURGICAL DRAPE received FDA 510(k) clearance on 1991-02-19, under 510(k) number K910495.

Who is the listed applicant for QUALTEX SURGICAL DRAPE?

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

What is the FDA product code for QUALTEX SURGICAL DRAPE?

The FDA product code for QUALTEX SURGICAL DRAPE is KKX.

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Other records listing Deroyal Industries, Inc. as applicant

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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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