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FDA 510(k)

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS

K-Number: K960048 · 1996-07-12

ApplicantSafetec of America, Inc.
Decision Date1996-07-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS 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 1996-07-12 under 510(k) number K960048. 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 EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS?

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS is a medical device that received FDA 510(k) clearance on 1996-07-12. The listed applicant is Safetec of America, Inc.. The 510(k) number is K960048.

When did EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS receive FDA 510(k) clearance?

EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS received FDA 510(k) clearance on 1996-07-12, under 510(k) number K960048.

Who is the listed applicant for EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS?

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 WITH SPILL CLEAN UP - PLUS?

The FDA product code for EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS 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.

K960073EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UPK953461CPR MASK & RELATED FAMILY KITSK952962EZ-PERSONAL PROTECTION KIT

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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