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FDA 510(k)

BUSSE SURGICAL DRAPE

K-Number: K082297 · 2008-12-09

ApplicantBusse Hospital Disposables, Inc.
Decision Date2008-12-09
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUSSE SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K082297. 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 BUSSE SURGICAL DRAPE?

BUSSE SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K082297.

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

BUSSE SURGICAL DRAPE received FDA 510(k) clearance on 2008-12-09, under 510(k) number K082297.

Who is the listed applicant for BUSSE SURGICAL DRAPE?

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

What is the FDA product code for BUSSE SURGICAL DRAPE?

The FDA product code for BUSSE SURGICAL DRAPE is KKX.

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Other records listing Busse Hospital Disposables, 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.

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEK093909BUSSE SURGICAL DRAPES IVK092212BUSSE SURGICAL DRAPES IIIK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETERK063018GLASS LOSS OF RESISTANCE SYRINGE

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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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