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)

GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE

K-Number: K990440 · 1999-08-12

ApplicantGentell
Decision Date1999-08-12
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE is the device name listed in this FDA 510(k) record. The listed applicant is Gentell. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K990440. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE?

GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Gentell. The 510(k) number is K990440.

When did GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE receive FDA 510(k) clearance?

GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE received FDA 510(k) clearance on 1999-08-12, under 510(k) number K990440.

Who is the listed applicant for GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE?

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

What is the FDA product code for GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE?

The FDA product code for GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE is MGQ.

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.

Related Devices (Code: MGQ)

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.

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.

↑