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FDA 510(k)

ISOLATION MASKS

K-Number: K893939 · 1989-07-14

ApplicantJames River Corp.
Decision Date1989-07-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLATION MASKS is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K893939. 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 ISOLATION MASKS?

ISOLATION MASKS is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is James River Corp.. The 510(k) number is K893939.

When did ISOLATION MASKS receive FDA 510(k) clearance?

ISOLATION MASKS received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893939.

Who is the listed applicant for ISOLATION MASKS?

The FDA 510(k) record lists James River Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLATION MASKS?

The FDA product code for ISOLATION MASKS is FXX.

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Other records listing James River Corp. 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.

K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEK894147VISULIN TRANSPARENT ADHESIVE DRESSINGK892580CARETOUCH EXAMINATION GLOVESK894034MODIFIED LABELING OF SURGICAL GLOVESK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVESK883802CARETEX CENTRAL SUPPLY WRAP

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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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