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FDA 510(k)

DRAPE UTILITY/SURGICAL STERILE DISPOSABLE

K-Number: K920284 · 1992-10-19

ApplicantTrinity Laboratories, Inc.
Decision Date1992-10-19
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPE UTILITY/SURGICAL STERILE DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1992-10-19 under 510(k) number K920284. 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 DRAPE UTILITY/SURGICAL STERILE DISPOSABLE?

DRAPE UTILITY/SURGICAL STERILE DISPOSABLE is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K920284.

When did DRAPE UTILITY/SURGICAL STERILE DISPOSABLE receive FDA 510(k) clearance?

DRAPE UTILITY/SURGICAL STERILE DISPOSABLE received FDA 510(k) clearance on 1992-10-19, under 510(k) number K920284.

Who is the listed applicant for DRAPE UTILITY/SURGICAL STERILE DISPOSABLE?

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

What is the FDA product code for DRAPE UTILITY/SURGICAL STERILE DISPOSABLE?

The FDA product code for DRAPE UTILITY/SURGICAL STERILE DISPOSABLE is KKX.

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Other records listing Trinity Laboratories, Inc. as applicant

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K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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Related Devices (Code: KKX)

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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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