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FDA 510(k)

KBM DENTAL MASK

K-Number: K884392 · 1988-11-18

ApplicantKawamoto Bandage Material Co., Ltd.
Decision Date1988-11-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KBM DENTAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Kawamoto Bandage Material Co., Ltd.. It received FDA 510(k) clearance on 1988-11-18 under 510(k) number K884392. 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 KBM DENTAL MASK?

KBM DENTAL MASK is a medical device that received FDA 510(k) clearance on 1988-11-18. The listed applicant is Kawamoto Bandage Material Co., Ltd.. The 510(k) number is K884392.

When did KBM DENTAL MASK receive FDA 510(k) clearance?

KBM DENTAL MASK received FDA 510(k) clearance on 1988-11-18, under 510(k) number K884392.

Who is the listed applicant for KBM DENTAL MASK?

The FDA 510(k) record lists Kawamoto Bandage Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KBM DENTAL MASK?

The FDA product code for KBM DENTAL MASK is FXX.

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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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