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FDA 510(k)

MASK SURGICAL

K-Number: K963568 · 1997-02-25

ApplicantThe Innovative Approach, Corp.
Decision Date1997-02-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASK SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is The Innovative Approach, Corp.. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K963568. 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 MASK SURGICAL?

MASK SURGICAL is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is The Innovative Approach, Corp.. The 510(k) number is K963568.

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

MASK SURGICAL received FDA 510(k) clearance on 1997-02-25, under 510(k) number K963568.

Who is the listed applicant for MASK SURGICAL?

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

What is the FDA product code for MASK SURGICAL?

The FDA product code for MASK SURGICAL 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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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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