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FDA 510(k)

RADIATION PROTECTION GLASSES

K-Number: K900970 · 1990-05-01

ApplicantInfab Corp.
Decision Date1990-05-01
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIATION PROTECTION GLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Infab Corp.. It received FDA 510(k) clearance on 1990-05-01 under 510(k) number K900970. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIATION PROTECTION GLASSES?

RADIATION PROTECTION GLASSES is a medical device that received FDA 510(k) clearance on 1990-05-01. The listed applicant is Infab Corp.. The 510(k) number is K900970.

When did RADIATION PROTECTION GLASSES receive FDA 510(k) clearance?

RADIATION PROTECTION GLASSES received FDA 510(k) clearance on 1990-05-01, under 510(k) number K900970.

Who is the listed applicant for RADIATION PROTECTION GLASSES?

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

What is the FDA product code for RADIATION PROTECTION GLASSES?

The FDA product code for RADIATION PROTECTION GLASSES is KPY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Infab 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.

K900972RADIATION PROTECTION GLOVESK901014RADIOGRAPHIC INTENSIFYING SCREENK901012RADIOGRAPHIC GRIDK901013RADIOGRAPHIC FILM CASSETTEK896289RADIATION PROTECTION APRON

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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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