The following data is part of a premarket notification filed by Kj Meditech Co., Ltd with the FDA for Kj Mask.
| Device ID | K103019 |
| 510k Number | K103019 |
| Device Name: | KJ MASK |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-06-09 |
| Summary: | summary |