ComfortGuard Surgical Gown, i600, Film Reinforced— 510(k) K163191
Substantially EquivalentGri Medical & Electrical Technology Co., Ltd.
FDA 510(k) clearance K163191 for ComfortGuard Surgical Gown, i600, Film Reinforced, Substantially Equivalent on 2017-02-27. Applicant: Gri Medical & Electrical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Gri Medical & Electrical Technology Co., Ltd.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing, CN
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