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FDA 510(k)

DEROYAL SURGICAL DRAPES BACKTABLE COVER

K-Number: K030908 · 2003-08-11

ApplicantDeroyal
Decision Date2003-08-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEROYAL SURGICAL DRAPES BACKTABLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal. It received FDA 510(k) clearance on 2003-08-11 under 510(k) number K030908. 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 DEROYAL SURGICAL DRAPES BACKTABLE COVER?

DEROYAL SURGICAL DRAPES BACKTABLE COVER is a medical device that received FDA 510(k) clearance on 2003-08-11. The listed applicant is Deroyal. The 510(k) number is K030908.

When did DEROYAL SURGICAL DRAPES BACKTABLE COVER receive FDA 510(k) clearance?

DEROYAL SURGICAL DRAPES BACKTABLE COVER received FDA 510(k) clearance on 2003-08-11, under 510(k) number K030908.

Who is the listed applicant for DEROYAL SURGICAL DRAPES BACKTABLE COVER?

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

What is the FDA product code for DEROYAL SURGICAL DRAPES BACKTABLE COVER?

The FDA product code for DEROYAL SURGICAL DRAPES BACKTABLE COVER is KKX.

Related Clinical Trials

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Other records listing Deroyal 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.

K041416EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERK033057DEROYAL SURGICAL GOWNS, STERILE, NON-STERILEK031408DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)K020753DEROYAL SURGICAL, UMBILICUP

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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