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FDA 510(k)

PATIENT DRAPE, SURGICAL

K-Number: K003670 · 2001-01-26

ApplicantAdvance Medical Designs, Inc.
Decision Date2001-01-26
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PATIENT DRAPE, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2001-01-26 under 510(k) number K003670. 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 PATIENT DRAPE, SURGICAL?

PATIENT DRAPE, SURGICAL is a medical device that received FDA 510(k) clearance on 2001-01-26. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K003670.

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

PATIENT DRAPE, SURGICAL received FDA 510(k) clearance on 2001-01-26, under 510(k) number K003670.

Who is the listed applicant for PATIENT DRAPE, SURGICAL?

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

What is the FDA product code for PATIENT DRAPE, SURGICAL?

The FDA product code for PATIENT DRAPE, SURGICAL is KKX.

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Other records listing Advance Medical Designs, 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.

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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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