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FDA 510(k)

EZ-PERSONAL PROTECTION KIT

K-Number: K952962 · 1995-09-27

ApplicantSafetec of America, Inc.
Decision Date1995-09-27
Product CodeFXX
Advisory CommitteeSU
DecisionUnknown

Device Summary

EZ-PERSONAL PROTECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Safetec of America, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K952962. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EZ-PERSONAL PROTECTION KIT?

EZ-PERSONAL PROTECTION KIT is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Safetec of America, Inc.. The 510(k) number is K952962.

When did EZ-PERSONAL PROTECTION KIT receive FDA 510(k) clearance?

EZ-PERSONAL PROTECTION KIT received FDA 510(k) clearance on 1995-09-27, under 510(k) number K952962.

Who is the listed applicant for EZ-PERSONAL PROTECTION KIT?

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

What is the FDA product code for EZ-PERSONAL PROTECTION KIT?

The FDA product code for EZ-PERSONAL PROTECTION KIT 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 Safetec of America, 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.

K960048EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUSK960073EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UPK953461CPR MASK & RELATED FAMILY KITS

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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