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FDA 510(k)

STERILE DISPOSABLE PN DRAPE SYSTEM

K-Number: K850912 · 1985-05-03

ApplicantBrant-Wald Surgicals, Inc.
Decision Date1985-05-03
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE PN DRAPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Brant-Wald Surgicals, Inc.. It received FDA 510(k) clearance on 1985-05-03 under 510(k) number K850912. 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 STERILE DISPOSABLE PN DRAPE SYSTEM?

STERILE DISPOSABLE PN DRAPE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-03. The listed applicant is Brant-Wald Surgicals, Inc.. The 510(k) number is K850912.

When did STERILE DISPOSABLE PN DRAPE SYSTEM receive FDA 510(k) clearance?

STERILE DISPOSABLE PN DRAPE SYSTEM received FDA 510(k) clearance on 1985-05-03, under 510(k) number K850912.

Who is the listed applicant for STERILE DISPOSABLE PN DRAPE SYSTEM?

The FDA 510(k) record lists Brant-Wald Surgicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE DISPOSABLE PN DRAPE SYSTEM?

The FDA product code for STERILE DISPOSABLE PN DRAPE SYSTEM 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 Brant-Wald Surgicals, 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.

K893634MODIFIED STERILIZATION OF TUR APRONS

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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