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FDA 510(k)

Grande Medical Masks, Model SF-600

K-Number: K232968 · 2024-06-06

ApplicantGolden Grande Corp.
Decision Date2024-06-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Grande Medical Masks, Model SF-600 is a medical device manufactured by Golden Grande Corp.. It received FDA 510(k) clearance on 2024-06-06 under approval number K232968. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Grande Medical Masks, Model SF-600?

Grande Medical Masks, Model SF-600 is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Golden Grande Corp.. The 510(k) number is K232968.

When was Grande Medical Masks, Model SF-600 approved by the FDA?

Grande Medical Masks, Model SF-600 received FDA 510(k) clearance on 2024-06-06, under approval number K232968.

What company makes Grande Medical Masks, Model SF-600?

Grande Medical Masks, Model SF-600 is manufactured by Golden Grande Corp..

What is the FDA product code for Grande Medical Masks, Model SF-600?

The FDA product code for Grande Medical Masks, Model SF-600 is FXX.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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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.

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