510(k) K172445
K172445 is an FDA 510(k) premarket notification submitted by Gri Medical & Electrical Technology Co., Ltd. for the device "RoyalGuard Surgical Gown, i600, Breathable". The FDA issued a decision of Substantially Equivalent on Dec 8, 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
- Dec 8, 2017
- Date Received
- Aug 14, 2017
- 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)