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FDA 510(k)

Cytosurg不可吸收PTFE膜，25mm x 30mm，Cytosurg不可吸收PTFE膜，12mm x 24mm

K号: K160493 · 2016-09-08

申请人Salvin Dental Specialties
决定日期2016-09-08
产品代码NPK
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决定实质等同

器械摘要

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm is the device name listed in this FDA 510(k) record. The listed applicant is Salvin Dental Specialties. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K160493. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm?

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Salvin Dental Specialties. The 510(k) number is K160493.

When did Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm receive FDA 510(k) clearance?

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm received FDA 510(k) clearance on 2016-09-08, under 510(k) number K160493.

Who is the listed applicant for Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm?

The FDA 510(k) record lists Salvin Dental Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm?

The FDA product code for Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm is NPK.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Salvin Dental Specialties为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K161857Salvin帐篷螺丝系统

相关器械（代码：NPK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221851Lumina-PTFE 钛合金Criteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic 不吸收性膜Cowellmedi Co., Ltd.K210797Bio-MEM Ti 强化膜B&Medi Co., Ltd.K201187Cytoplast钛增强PTFE膜Osteogenics Biomedical, Inc.K171774RPM 加强型 PTFE 网格Osteogenics Biomedical, Inc.

官方来源

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