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FDA 510(k)

SURGICAL GOWNS, SHEETS

K-Number: K781959 · 1979-01-10

ApplicantConvertors
Decision Date1979-01-10
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWNS, SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781959. 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 SURGICAL GOWNS, SHEETS?

SURGICAL GOWNS, SHEETS is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Convertors. The 510(k) number is K781959.

When did SURGICAL GOWNS, SHEETS receive FDA 510(k) clearance?

SURGICAL GOWNS, SHEETS received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781959.

Who is the listed applicant for SURGICAL GOWNS, SHEETS?

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

What is the FDA product code for SURGICAL GOWNS, SHEETS?

The FDA product code for SURGICAL GOWNS, SHEETS is KKX.

Related Clinical Trials

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.

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Other records listing Convertors 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.

K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELSK790234DRAPE PACKS, SURGICAL GOWNSK781534SURG-O-PAK PREP PADK781099SURGICAL GOWNS AND DRAPESK780169MASK, SURGICALK771929PEDIATRICS GOWN

View all 10 devices →

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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