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)

A-COMPANY SELF-LIGATING APPLIANCE

K-Number: K852800 · 1985-07-31

ApplicantA Company, Inc.
Decision Date1985-07-31
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-COMPANY SELF-LIGATING APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is A Company, Inc.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K852800. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-COMPANY SELF-LIGATING APPLIANCE?

A-COMPANY SELF-LIGATING APPLIANCE is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is A Company, Inc.. The 510(k) number is K852800.

When did A-COMPANY SELF-LIGATING APPLIANCE receive FDA 510(k) clearance?

A-COMPANY SELF-LIGATING APPLIANCE received FDA 510(k) clearance on 1985-07-31, under 510(k) number K852800.

Who is the listed applicant for A-COMPANY SELF-LIGATING APPLIANCE?

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

What is the FDA product code for A-COMPANY SELF-LIGATING APPLIANCE?

The FDA product code for A-COMPANY SELF-LIGATING APPLIANCE is EJF.

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 A Company, 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.

K897195A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)K852600A-COMPANY ELASTOMERIC CHAIN DISPENSERK852596A-COMPANY ELASTIC LIGATURE RINGSK852598A-COMPANY SEPARATING ELASTICSK852599A-COMPANY ELASTOMERIC TUBINGK852670A-COMPANY ESPREE SAFETY HEADGEAR

View all 14 devices →

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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.

↑