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FDA 510(k)

BOUNDARY SINGLE-USE DRAPES

K-Number: K813450 · 1982-01-22

ApplicantThe Buckeye Cellulose Corp.
Decision Date1982-01-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SINGLE-USE DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is The Buckeye Cellulose Corp.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813450. 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 BOUNDARY SINGLE-USE DRAPES?

BOUNDARY SINGLE-USE DRAPES is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is The Buckeye Cellulose Corp.. The 510(k) number is K813450.

When did BOUNDARY SINGLE-USE DRAPES receive FDA 510(k) clearance?

BOUNDARY SINGLE-USE DRAPES received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813450.

Who is the listed applicant for BOUNDARY SINGLE-USE DRAPES?

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

What is the FDA product code for BOUNDARY SINGLE-USE DRAPES?

The FDA product code for BOUNDARY SINGLE-USE DRAPES is KKX.

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Other records listing The Buckeye Cellulose Corp. 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.

K822925BOUNDARY SINGLE-USE GOWNSK823173ARRIRM SCRUB BRUSH/SPONGEK821564BOUNDARY PROCESS CHANGEK820758BOUNDARY SINGLE-USE CRANIOTOMY SHEETK820116BOUNDARYK813390BONDARY SINGLE-USE OR GOWN

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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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