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FDA 510(k)

STI DRAPE SHEET STYLE 1908

K-Number: K904112 · 1990-10-30

ApplicantSterilizer Technologies Corp.
Decision Date1990-10-30
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STI DRAPE SHEET STYLE 1908 is the device name listed in this FDA 510(k) record. The listed applicant is Sterilizer Technologies Corp.. It received FDA 510(k) clearance on 1990-10-30 under 510(k) number K904112. 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 STI DRAPE SHEET STYLE 1908?

STI DRAPE SHEET STYLE 1908 is a medical device that received FDA 510(k) clearance on 1990-10-30. The listed applicant is Sterilizer Technologies Corp.. The 510(k) number is K904112.

When did STI DRAPE SHEET STYLE 1908 receive FDA 510(k) clearance?

STI DRAPE SHEET STYLE 1908 received FDA 510(k) clearance on 1990-10-30, under 510(k) number K904112.

Who is the listed applicant for STI DRAPE SHEET STYLE 1908?

The FDA 510(k) record lists Sterilizer Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STI DRAPE SHEET STYLE 1908?

The FDA product code for STI DRAPE SHEET STYLE 1908 is KKX.

Related Clinical Trials

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Other records listing Sterilizer Technologies Corp. 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.

K890359RESUBMITTED STC SERIES 8600 AUTOCLAVE

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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