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FDA 510(k)

TREATED BARRIER INCISE DRAPE

K-Number: K790431 · 1979-05-04

ApplicantSurgikos, Inc.
Decision Date1979-05-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TREATED BARRIER INCISE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-05-04 under 510(k) number K790431. 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 TREATED BARRIER INCISE DRAPE?

TREATED BARRIER INCISE DRAPE is a medical device that received FDA 510(k) clearance on 1979-05-04. The listed applicant is Surgikos, Inc.. The 510(k) number is K790431.

When did TREATED BARRIER INCISE DRAPE receive FDA 510(k) clearance?

TREATED BARRIER INCISE DRAPE received FDA 510(k) clearance on 1979-05-04, under 510(k) number K790431.

Who is the listed applicant for TREATED BARRIER INCISE DRAPE?

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

What is the FDA product code for TREATED BARRIER INCISE DRAPE?

The FDA product code for TREATED BARRIER INCISE DRAPE is KKX.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPE

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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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