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FDA 510(k)

FACELOCK FILTER MASK

K-Number: K890128 · 1989-02-14

ApplicantAlpha Protech, Inc.
Decision Date1989-02-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FACELOCK FILTER MASK is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Protech, Inc.. It received FDA 510(k) clearance on 1989-02-14 under 510(k) number K890128. 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 FACELOCK FILTER MASK?

FACELOCK FILTER MASK is a medical device that received FDA 510(k) clearance on 1989-02-14. The listed applicant is Alpha Protech, Inc.. The 510(k) number is K890128.

When did FACELOCK FILTER MASK receive FDA 510(k) clearance?

FACELOCK FILTER MASK received FDA 510(k) clearance on 1989-02-14, under 510(k) number K890128.

Who is the listed applicant for FACELOCK FILTER MASK?

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

What is the FDA product code for FACELOCK FILTER MASK?

The FDA product code for FACELOCK FILTER 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 Alpha Protech, 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.

K092824N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695

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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