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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 the device name listed in this FDA 510(k) record. The listed applicant is Golden Grande Corp.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) 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. The listed applicant is Golden Grande Corp.. The 510(k) number is K232968.

When did Grande Medical Masks, Model SF-600 receive FDA 510(k) clearance?

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

Who is the listed applicant for Grande Medical Masks, Model SF-600?

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

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.

Related Devices (Code: FXX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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