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FDA 510(k)

FACE MASK, SURGICAL MASK, NON-STERILE

K-Number: K970835 · 1997-09-03

ApplicantTucker & Associates
Decision Date1997-09-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FACE MASK, SURGICAL MASK, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Tucker & Associates. It received FDA 510(k) clearance on 1997-09-03 under 510(k) number K970835. 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 FACE MASK, SURGICAL MASK, NON-STERILE?

FACE MASK, SURGICAL MASK, NON-STERILE is a medical device that received FDA 510(k) clearance on 1997-09-03. The listed applicant is Tucker & Associates. The 510(k) number is K970835.

When did FACE MASK, SURGICAL MASK, NON-STERILE receive FDA 510(k) clearance?

FACE MASK, SURGICAL MASK, NON-STERILE received FDA 510(k) clearance on 1997-09-03, under 510(k) number K970835.

Who is the listed applicant for FACE MASK, SURGICAL MASK, NON-STERILE?

The FDA 510(k) record lists Tucker & Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACE MASK, SURGICAL MASK, NON-STERILE?

The FDA product code for FACE MASK, SURGICAL MASK, NON-STERILE 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 Tucker & Associates 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.

K022256SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREENK980827LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELINGK980802NITRILE EXAM GLOVE, POWDER-FREE, BLUE

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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