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FDA 510(k)

DISPOSABLE SURGICAL DRAPES AND ACCESSORIES

K-Number: K861531 · 1986-05-23

ApplicantMedical Concepts Development, Inc.
Decision Date1986-05-23
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGICAL DRAPES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Concepts Development, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861531. 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 DISPOSABLE SURGICAL DRAPES AND ACCESSORIES?

DISPOSABLE SURGICAL DRAPES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Medical Concepts Development, Inc.. The 510(k) number is K861531.

When did DISPOSABLE SURGICAL DRAPES AND ACCESSORIES receive FDA 510(k) clearance?

DISPOSABLE SURGICAL DRAPES AND ACCESSORIES received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861531.

Who is the listed applicant for DISPOSABLE SURGICAL DRAPES AND ACCESSORIES?

The FDA 510(k) record lists Medical Concepts Development, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SURGICAL DRAPES AND ACCESSORIES?

The FDA product code for DISPOSABLE SURGICAL DRAPES AND ACCESSORIES 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 Medical Concepts Development, 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.

K020581COLOSHIELD COLONOSCOPY DRAPE MODEL E2000K000442ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XXK924794TRANSPARENT ADHESIVE DRESSINGK870044MCD SPECIALTY BRAND NEEDLE COUNTERSK861530SURGICAL PACKS, KITS AND TRAYS

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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