NQB
- 产品代码
- NQB
- 器械名称
- Conformer, Ophthalmic, Biological Tissue
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 886.3130
- FDA 专业组
- Ophthalmic
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
- 标记
- 属植入器械
- FDA 历史累计 510(k)
- 1 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
FDA 官方分类页: NQB
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。