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FDA 510(k)

BARRIER* X-RAY CASSETTE DRAPE

K-Number: K791440 · 1979-08-28

ApplicantSurgikos, Inc.
Decision Date1979-08-28
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER* X-RAY CASSETTE 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 1979-08-28 under 510(k) number K791440. 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 BARRIER* X-RAY CASSETTE DRAPE?

BARRIER* X-RAY CASSETTE DRAPE is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Surgikos, Inc.. The 510(k) number is K791440.

When did BARRIER* X-RAY CASSETTE DRAPE receive FDA 510(k) clearance?

BARRIER* X-RAY CASSETTE DRAPE received FDA 510(k) clearance on 1979-08-28, under 510(k) number K791440.

Who is the listed applicant for BARRIER* X-RAY CASSETTE 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 BARRIER* X-RAY CASSETTE DRAPE?

The FDA product code for BARRIER* X-RAY CASSETTE 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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