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)

SOOTHE-N-SEAL CANKER SORE RELIEF

K-Number: K991923 · 1999-09-02

ApplicantClosure Medical Corp.
Decision Date1999-09-02
Product CodeMZW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOOTHE-N-SEAL CANKER SORE RELIEF is the device name listed in this FDA 510(k) record. The listed applicant is Closure Medical Corp.. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K991923. The device is classified under product code MZW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOOTHE-N-SEAL CANKER SORE RELIEF?

SOOTHE-N-SEAL CANKER SORE RELIEF is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is Closure Medical Corp.. The 510(k) number is K991923.

When did SOOTHE-N-SEAL CANKER SORE RELIEF receive FDA 510(k) clearance?

SOOTHE-N-SEAL CANKER SORE RELIEF received FDA 510(k) clearance on 1999-09-02, under 510(k) number K991923.

Who is the listed applicant for SOOTHE-N-SEAL CANKER SORE RELIEF?

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

What is the FDA product code for SOOTHE-N-SEAL CANKER SORE RELIEF?

The FDA product code for SOOTHE-N-SEAL CANKER SORE RELIEF is MZW.

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 Closure Medical 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.

K002338LIQUIDERM LIQUID ADHESIVE BANDAGEK980159OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01

Related Devices (Code: MZW)

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.

K073209MAXCEM 2Kerr Corporation

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.

↑