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FDA 510(k)

SURGICAL MASKS

K-Number: K111559 · 2011-09-16

ApplicantShanghai Neo-Medical Import & Export Co., Ltd.
Decision Date2011-09-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Neo-Medical Import & Export Co., Ltd.. It received FDA 510(k) clearance on 2011-09-16 under 510(k) number K111559. 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 SURGICAL MASKS?

SURGICAL MASKS is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Shanghai Neo-Medical Import & Export Co., Ltd.. The 510(k) number is K111559.

When did SURGICAL MASKS receive FDA 510(k) clearance?

SURGICAL MASKS received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111559.

Who is the listed applicant for SURGICAL MASKS?

The FDA 510(k) record lists Shanghai Neo-Medical Import & Export Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL MASKS?

The FDA product code for SURGICAL MASKS is FXX.

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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

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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