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FDA 510(k)

C-MASK

K-Number: K882882 · 1988-08-10

ApplicantPromedica Products, Inc.
Decision Date1988-08-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C-MASK is the device name listed in this FDA 510(k) record. The listed applicant is Promedica Products, Inc.. It received FDA 510(k) clearance on 1988-08-10 under 510(k) number K882882. 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 C-MASK?

C-MASK is a medical device that received FDA 510(k) clearance on 1988-08-10. The listed applicant is Promedica Products, Inc.. The 510(k) number is K882882.

When did C-MASK receive FDA 510(k) clearance?

C-MASK received FDA 510(k) clearance on 1988-08-10, under 510(k) number K882882.

Who is the listed applicant for C-MASK?

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

What is the FDA product code for C-MASK?

The FDA product code for C-MASK is FXX.

Other records listing Promedica Products, 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.

K913101PETERS CARDIOFLON(TM) SUTUREK913102PETERS CARDIONYL(TM) SUTUREK892768PATIENT EXAMINATION GLOVES (POLY)K883412THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)K882883C-MASK(FLAT)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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