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FDA 510(k)

TECNOL FLUIDSHIELD INFECTION CONTROL MASK

K-Number: K915817 · 1993-01-27

ApplicantTecnol Medical Products, Inc.
Decision Date1993-01-27
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECNOL FLUIDSHIELD INFECTION CONTROL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K915817. 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 TECNOL FLUIDSHIELD INFECTION CONTROL MASK?

TECNOL FLUIDSHIELD INFECTION CONTROL MASK is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K915817.

When did TECNOL FLUIDSHIELD INFECTION CONTROL MASK receive FDA 510(k) clearance?

TECNOL FLUIDSHIELD INFECTION CONTROL MASK received FDA 510(k) clearance on 1993-01-27, under 510(k) number K915817.

Who is the listed applicant for TECNOL FLUIDSHIELD INFECTION CONTROL MASK?

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

What is the FDA product code for TECNOL FLUIDSHIELD INFECTION CONTROL MASK?

The FDA product code for TECNOL FLUIDSHIELD INFECTION CONTROL 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 Medical Products, 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.

K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALK970448PCM 2000; ISOLAIR APR MODEL 2735K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030

View all 21 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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