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FDA 510(k)

AM TM SYRGICAL DRAPES

K-Number: K882643 · 1989-03-03

ApplicantHenley Intl.
Decision Date1989-03-03
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

AM TM SYRGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1989-03-03 under 510(k) number K882643. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AM TM SYRGICAL DRAPES?

AM TM SYRGICAL DRAPES is a medical device that received FDA 510(k) clearance on 1989-03-03. The listed applicant is Henley Intl.. The 510(k) number is K882643.

When did AM TM SYRGICAL DRAPES receive FDA 510(k) clearance?

AM TM SYRGICAL DRAPES received FDA 510(k) clearance on 1989-03-03, under 510(k) number K882643.

Who is the listed applicant for AM TM SYRGICAL DRAPES?

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

What is the FDA product code for AM TM SYRGICAL DRAPES?

The FDA product code for AM TM SYRGICAL DRAPES is KKX.

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Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926279UPPER BODY EXERCISERK926278STAIR CLIMBERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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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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