510(k) K103019
K103019 is an FDA 510(k) premarket notification submitted by Kj Meditech Co., Ltd. for the device "KJ MASK". The FDA issued a decision of Substantially Equivalent on June 9, 2011. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Kj Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2011
- Date Received
- October 12, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headgear, Extraoral, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5500
- Review Panel
- DE
- Submission Type