Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PLASTIC OR GLASS MAGNIFIER

K-Number: K820375 · 1982-06-14

ApplicantGazelle Corp.
Decision Date1982-06-14
Product CodeHJF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PLASTIC OR GLASS MAGNIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Gazelle Corp.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K820375. The device is classified under product code HJF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTIC OR GLASS MAGNIFIER?

PLASTIC OR GLASS MAGNIFIER is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Gazelle Corp.. The 510(k) number is K820375.

When did PLASTIC OR GLASS MAGNIFIER receive FDA 510(k) clearance?

PLASTIC OR GLASS MAGNIFIER received FDA 510(k) clearance on 1982-06-14, under 510(k) number K820375.

Who is the listed applicant for PLASTIC OR GLASS MAGNIFIER?

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

What is the FDA product code for PLASTIC OR GLASS MAGNIFIER?

The FDA product code for PLASTIC OR GLASS MAGNIFIER is HJF.

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 Gazelle 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.

K844716MAGNIFYING SPECTACLES W/PLASTIC LENSES

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.

↑