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FDA 510(k)

RADIATION PROTECTION APRON

K-Number: K896289 · 1989-12-14

ApplicantInfab Corp.
Decision Date1989-12-14
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIATION PROTECTION APRON is the device name listed in this FDA 510(k) record. The listed applicant is Infab Corp.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K896289. 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 APRON?

RADIATION PROTECTION APRON is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Infab Corp.. The 510(k) number is K896289.

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

RADIATION PROTECTION APRON received FDA 510(k) clearance on 1989-12-14, under 510(k) number K896289.

Who is the listed applicant for RADIATION PROTECTION APRON?

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 APRON?

The FDA product code for RADIATION PROTECTION APRON 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.

K900970RADIATION PROTECTION GLASSESK900972RADIATION PROTECTION GLOVESK901014RADIOGRAPHIC INTENSIFYING SCREENK901012RADIOGRAPHIC GRIDK901013RADIOGRAPHIC FILM CASSETTE

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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