510(k) K173108
K173108 is an FDA 510(k) premarket notification submitted by Sejong Medical Co., Ltd. for the device "Smoklean". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Sejong Medical Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2018
- Date Received
- September 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Exhaust, Surgical
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type