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)

POWERED EYE WASH

K-Number: K893829 · 1989-11-14

ApplicantSacks Model Makers
Decision Date1989-11-14
Product CodeMSI
DecisionSubstantially Equivalent

Device Summary

POWERED EYE WASH is the device name listed in this FDA 510(k) record. The listed applicant is Sacks Model Makers. It received FDA 510(k) clearance on 1989-11-14 under 510(k) number K893829. The device is classified under product code MSI. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED EYE WASH?

POWERED EYE WASH is a medical device that received FDA 510(k) clearance on 1989-11-14. The listed applicant is Sacks Model Makers. The 510(k) number is K893829.

When did POWERED EYE WASH receive FDA 510(k) clearance?

POWERED EYE WASH received FDA 510(k) clearance on 1989-11-14, under 510(k) number K893829.

Who is the listed applicant for POWERED EYE WASH?

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

What is the FDA product code for POWERED EYE WASH?

The FDA product code for POWERED EYE WASH is MSI.

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

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.

↑