BOSS
K号: K253723 · 2026-06-16
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决定日期2026-06-16
产品代码NPM
咨询委员会DE
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器械摘要
BOSS is the device name listed in this FDA 510(k) record. The listed applicant is Medpark Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253723. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BOSS?
BOSS is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Medpark Co., Ltd.. The 510(k) number is K253723.
When did BOSS receive FDA 510(k) clearance?
BOSS received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253723.
Who is the listed applicant for BOSS?
The FDA 510(k) record lists Medpark Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BOSS?
The FDA product code for BOSS is NPM.
列明Medpark Co., Ltd.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。
相关器械（代码：NPM）
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。
K254210REBOHIL（BGM-1，BGM-2，BGM-3，BGM-4，BGM-5）Hyundai Bioland Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133异种移植牛骨颗粒Collagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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