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FDA 510(k)

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK

K-Number: K911891 · 1991-07-12

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1991-07-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1991-07-12 under 510(k) number K911891. 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 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK?

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK is a medical device that received FDA 510(k) clearance on 1991-07-12. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K911891.

When did FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK receive FDA 510(k) clearance?

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK received FDA 510(k) clearance on 1991-07-12, under 510(k) number K911891.

Who is the listed applicant for FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK?

The FDA product code for FLUIDSHIELD(TM) CONE CLASSIC(TM) II 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.

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Other records listing Tecnol New Jersey Wound Care, Inc. 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.

K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK893702TECNOL GAITERS PRODUCT NUMBER 47725-010K891187TECNOL NASO-GASTRIC TUBE HOLDER

View all 35 devices →

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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