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FDA 510(k)

SURGIFRESH SUB-MICRON MASK NO. 901008-000

K-Number: K893417 · 1989-06-22

ApplicantTexas Medical Products, Inc.
Decision Date1989-06-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIFRESH SUB-MICRON MASK NO. 901008-000 is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K893417. 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 SURGIFRESH SUB-MICRON MASK NO. 901008-000?

SURGIFRESH SUB-MICRON MASK NO. 901008-000 is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K893417.

When did SURGIFRESH SUB-MICRON MASK NO. 901008-000 receive FDA 510(k) clearance?

SURGIFRESH SUB-MICRON MASK NO. 901008-000 received FDA 510(k) clearance on 1989-06-22, under 510(k) number K893417.

Who is the listed applicant for SURGIFRESH SUB-MICRON MASK NO. 901008-000?

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

What is the FDA product code for SURGIFRESH SUB-MICRON MASK NO. 901008-000?

The FDA product code for SURGIFRESH SUB-MICRON MASK NO. 901008-000 is FXX.

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Other records listing Texas 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.

K870932SURGIFRESH SURGICAL SMOKE REMOVALK851575DR. BRUNO LNAGE MINI PHOTOMETERK830634CARDIOTOMY FILTERK813587DISPOSABLE THORACIC CATHETERK810532DISPOSABLE STOPCOCKK810515DISPOSABLE 2-STAGE CANNULA

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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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