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FDA 510(k)

DISPOSABLE SURGICAL MASK (MODIFIED)

K-Number: K931580 · 1994-05-02

ApplicantBam Corp., Ltd.
Decision Date1994-05-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGICAL MASK (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Bam Corp., Ltd.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K931580. 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 DISPOSABLE SURGICAL MASK (MODIFIED)?

DISPOSABLE SURGICAL MASK (MODIFIED) is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Bam Corp., Ltd.. The 510(k) number is K931580.

When did DISPOSABLE SURGICAL MASK (MODIFIED) receive FDA 510(k) clearance?

DISPOSABLE SURGICAL MASK (MODIFIED) received FDA 510(k) clearance on 1994-05-02, under 510(k) number K931580.

Who is the listed applicant for DISPOSABLE SURGICAL MASK (MODIFIED)?

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

What is the FDA product code for DISPOSABLE SURGICAL MASK (MODIFIED)?

The FDA product code for DISPOSABLE SURGICAL MASK (MODIFIED) 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.

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Other records listing Bam Corp., Ltd. 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.

K093835BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWNK933748SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

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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