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FDA 510(k)

BARRIER EXTRA PROTECTION PLUS FACE MASK

K-Number: K920108 · 1994-02-10

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1994-02-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER EXTRA PROTECTION PLUS FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K920108. 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 BARRIER EXTRA PROTECTION PLUS FACE MASK?

BARRIER EXTRA PROTECTION PLUS FACE MASK is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K920108.

When did BARRIER EXTRA PROTECTION PLUS FACE MASK receive FDA 510(k) clearance?

BARRIER EXTRA PROTECTION PLUS FACE MASK received FDA 510(k) clearance on 1994-02-10, under 510(k) number K920108.

Who is the listed applicant for BARRIER EXTRA PROTECTION PLUS FACE MASK?

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

What is the FDA product code for BARRIER EXTRA PROTECTION PLUS FACE MASK?

The FDA product code for BARRIER EXTRA PROTECTION PLUS FACE MASK is FXX.

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Other records listing Johnson & Johnson Medical, 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.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

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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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