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FDA 510(k)

IMC SURGICAL DRAPE

K-Number: K100208 · 2010-04-20

ApplicantInternational Medsurg Connection
Decision Date2010-04-20
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMC SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is International Medsurg Connection. It received FDA 510(k) clearance on 2010-04-20 under 510(k) number K100208. 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 IMC SURGICAL DRAPE?

IMC SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2010-04-20. The listed applicant is International Medsurg Connection. The 510(k) number is K100208.

When did IMC SURGICAL DRAPE receive FDA 510(k) clearance?

IMC SURGICAL DRAPE received FDA 510(k) clearance on 2010-04-20, under 510(k) number K100208.

Who is the listed applicant for IMC SURGICAL DRAPE?

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

What is the FDA product code for IMC SURGICAL DRAPE?

The FDA product code for IMC SURGICAL DRAPE is KKX.

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Other records listing International Medsurg Connection 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.

K110656IMC BLOOD COLLECTION NEEDLEK110882IMC INSULIN SYRINGEK102584IMC HYPODERMIC NEEDLEK102969IMC PISTON SYRINGESK100991IMC SURGICAL DRAPEK100846IMC SURGICAL FACE MASK

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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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