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FDA 510(k)

MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493

K-Number: K903486 · 1990-10-23

ApplicantPennsylvania Association For the Blind
Decision Date1990-10-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 is the device name listed in this FDA 510(k) record. The listed applicant is Pennsylvania Association For the Blind. It received FDA 510(k) clearance on 1990-10-23 under 510(k) number K903486. 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-DISPOSABLE NSN 6510-00-982-7493?

MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 is a medical device that received FDA 510(k) clearance on 1990-10-23. The listed applicant is Pennsylvania Association For the Blind. The 510(k) number is K903486.

When did MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 receive FDA 510(k) clearance?

MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 received FDA 510(k) clearance on 1990-10-23, under 510(k) number K903486.

Who is the listed applicant for MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493?

The FDA 510(k) record lists Pennsylvania Association For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493?

The FDA product code for MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pennsylvania Association For the Blind 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.

K880785SKILCRAFT

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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