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FDA 510(k)

SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM

K-Number: K870124 · 1987-02-04

ApplicantAvery Intl.
Decision Date1987-02-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM is the device name listed in this FDA 510(k) record. The listed applicant is Avery Intl.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K870124. 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 SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM?

SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Avery Intl.. The 510(k) number is K870124.

When did SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM receive FDA 510(k) clearance?

SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM received FDA 510(k) clearance on 1987-02-04, under 510(k) number K870124.

Who is the listed applicant for SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM?

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

What is the FDA product code for SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM?

The FDA product code for SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM is KKX.

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Other records listing Avery 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.

K870021MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGEK870092MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILMK870093MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILMK870091IV SECUREMENT DEVICE USING PCCE THERMO. FILMK870090IV SECUREMENT DEVICE USING HYTREL THERMO. FILMK870020IV SECUREMENT DEVICE

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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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