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FDA 510(k)

EYE TRAY

K-Number: K970722 · 1997-03-31

ApplicantTrinity Laboratories, Inc.
Decision Date1997-03-31
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EYE TRAY 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 1997-03-31 under 510(k) number K970722. 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 EYE TRAY?

EYE TRAY is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K970722.

When did EYE TRAY receive FDA 510(k) clearance?

EYE TRAY received FDA 510(k) clearance on 1997-03-31, under 510(k) number K970722.

Who is the listed applicant for EYE TRAY?

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 EYE TRAY?

The FDA product code for EYE TRAY is KKX.

Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLEK964921BASIC BIOPSY TRAY. DISPOSABLE, STERILE

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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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