510(k) K163191
K163191 is an FDA 510(k) premarket notification submitted by Gri Medical & Electrical Technology Co., Ltd. for the device "ComfortGuard Surgical Gown, i600, Film Reinforced". The FDA issued a decision of Substantially Equivalent on Feb 27, 2017. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Gri Medical & Electrical Technology Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 2017
- Date Received
- Nov 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
- 510(k)