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FDA 510(k)

TIGER FLAT SURGICAL MASK

K-Number: K102713 · 2011-01-25

ApplicantTiger Medical Products, Ltd.
Decision Date2011-01-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIGER FLAT SURGICAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Tiger Medical Products, Ltd.. It received FDA 510(k) clearance on 2011-01-25 under 510(k) number K102713. 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 TIGER FLAT SURGICAL MASK?

TIGER FLAT SURGICAL MASK is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Tiger Medical Products, Ltd.. The 510(k) number is K102713.

When did TIGER FLAT SURGICAL MASK receive FDA 510(k) clearance?

TIGER FLAT SURGICAL MASK received FDA 510(k) clearance on 2011-01-25, under 510(k) number K102713.

Who is the listed applicant for TIGER FLAT SURGICAL MASK?

The FDA 510(k) record lists Tiger Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIGER FLAT SURGICAL MASK?

The FDA product code for TIGER FLAT SURGICAL MASK is FXX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tiger Medical Products, Ltd. as applicant

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.

K122717FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASKK120690INSULIN PEN NEEDLEK110697TIGER SYRINGES AND NEEDLESK041311TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)

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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