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FDA 510(k)

EARLOOP FACE MASK

K-Number: K990719 · 1999-07-12

ApplicantShuenn Bao Shing Corp.
Decision Date1999-07-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EARLOOP FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Shuenn Bao Shing Corp.. It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K990719. 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 EARLOOP FACE MASK?

EARLOOP FACE MASK is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Shuenn Bao Shing Corp.. The 510(k) number is K990719.

When did EARLOOP FACE MASK receive FDA 510(k) clearance?

EARLOOP FACE MASK received FDA 510(k) clearance on 1999-07-12, under 510(k) number K990719.

Who is the listed applicant for EARLOOP FACE MASK?

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

What is the FDA product code for EARLOOP FACE MASK?

The FDA product code for EARLOOP FACE MASK 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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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