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FDA 510(k)

FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR

K-Number: K932137 · 1994-04-15

ApplicantTecnol Medical Products, Inc.
Decision Date1994-04-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR 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 1994-04-15 under 510(k) number K932137. 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 SURGICAL/PROCEDURE MASK/M. WITH VISOR?

FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K932137.

When did FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR receive FDA 510(k) clearance?

FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR received FDA 510(k) clearance on 1994-04-15, under 510(k) number K932137.

Who is the listed applicant for FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR?

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 FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR?

The FDA product code for FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR is FXX.

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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 2735K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030

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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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