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FDA 510(k)

OPERATING ROOM TOWELS

K-Number: K981823 · 1998-08-11

ApplicantBaldur Systems Corp.
Decision Date1998-08-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPERATING ROOM TOWELS is the device name listed in this FDA 510(k) record. The listed applicant is Baldur Systems Corp.. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K981823. 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 OPERATING ROOM TOWELS?

OPERATING ROOM TOWELS is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Baldur Systems Corp.. The 510(k) number is K981823.

When did OPERATING ROOM TOWELS receive FDA 510(k) clearance?

OPERATING ROOM TOWELS received FDA 510(k) clearance on 1998-08-11, under 510(k) number K981823.

Who is the listed applicant for OPERATING ROOM TOWELS?

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

What is the FDA product code for OPERATING ROOM TOWELS?

The FDA product code for OPERATING ROOM TOWELS 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 Baldur Systems 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.

K974347BALDUR NON-STERILE COTTON SPONGESK892684PATIENT EXAMINATION GLOVES (LATEX)K891728LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)K891727LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)K891726VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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