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FDA 510(k)

STERILE SURGICAL DRAPES AND SHEETS

K-Number: K896367 · 1989-12-04

ApplicantClinitech, Inc.
Decision Date1989-12-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SURGICAL DRAPES AND SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Clinitech, Inc.. It received FDA 510(k) clearance on 1989-12-04 under 510(k) number K896367. 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 STERILE SURGICAL DRAPES AND SHEETS?

STERILE SURGICAL DRAPES AND SHEETS is a medical device that received FDA 510(k) clearance on 1989-12-04. The listed applicant is Clinitech, Inc.. The 510(k) number is K896367.

When did STERILE SURGICAL DRAPES AND SHEETS receive FDA 510(k) clearance?

STERILE SURGICAL DRAPES AND SHEETS received FDA 510(k) clearance on 1989-12-04, under 510(k) number K896367.

Who is the listed applicant for STERILE SURGICAL DRAPES AND SHEETS?

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

What is the FDA product code for STERILE SURGICAL DRAPES AND SHEETS?

The FDA product code for STERILE SURGICAL DRAPES AND SHEETS is KKX.

Related Clinical Trials

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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Other records listing Clinitech, 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.

K895667STERILE SURGICAL GOWNK864311STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)

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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