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FDA 510(k)

MASKS SURGICAL DENTAL

K-Number: K900088 · 1990-03-08

ApplicantKab Gloves Unltd.
Decision Date1990-03-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASKS SURGICAL DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Kab Gloves Unltd.. It received FDA 510(k) clearance on 1990-03-08 under 510(k) number K900088. 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 MASKS SURGICAL DENTAL?

MASKS SURGICAL DENTAL is a medical device that received FDA 510(k) clearance on 1990-03-08. The listed applicant is Kab Gloves Unltd.. The 510(k) number is K900088.

When did MASKS SURGICAL DENTAL receive FDA 510(k) clearance?

MASKS SURGICAL DENTAL received FDA 510(k) clearance on 1990-03-08, under 510(k) number K900088.

Who is the listed applicant for MASKS SURGICAL DENTAL?

The FDA 510(k) record lists Kab Gloves Unltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASKS SURGICAL DENTAL?

The FDA product code for MASKS SURGICAL DENTAL 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 Kab Gloves Unltd. 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.

K900135CU-75 VISIBLE LIGHT-CURING UNITK900631SALIVA ABSORBER - DENTALK900089FG DIAMOND BURRS

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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