The following data is part of a premarket notification filed by Kwang Myung Daicom Inc with the FDA for Protraction Face Mask, Reverse Pull Face Mask Model Km-pvs, Km-pis, Km-pvm, Km-pim, Model Km-fms, Km-fml, Km-fmf.
| Device ID | K111169 |
| 510k Number | K111169 |
| Device Name: | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | KWANG MYUNG DAICOM INC 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KWANG MYUNG DAICOM INC 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 | 2011-04-26 |
| Decision Date | 2011-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190707005061 | K111169 | 000 |
| 10195291008235 | K111169 | 000 |
| 10195291008204 | K111169 | 000 |
| 10195291008198 | K111169 | 000 |
| 10195291008181 | K111169 | 000 |
| 10195291008167 | K111169 | 000 |
| 10195291008150 | K111169 | 000 |
| 10195291008143 | K111169 | 000 |
| 10195291008228 | K111169 | 000 |
| 10195291008211 | K111169 | 000 |
| 10195291008242 | K111169 | 000 |
| 10195291008259 | K111169 | 000 |
| 00195291008269 | K111169 | 000 |
| 00195291009174 | K111169 | 000 |
| 00195291009167 | K111169 | 000 |
| 00195291009150 | K111169 | 000 |
| 00195291009143 | K111169 | 000 |
| 00195291009136 | K111169 | 000 |
| 10195291009126 | K111169 | 000 |
| 10195291009119 | K111169 | 000 |
| 10195291009102 | K111169 | 000 |
| 10195291009096 | K111169 | 000 |
| 10195291008174 | K111169 | 000 |