The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Keles Facemask.
| Device ID | K041718 |
| 510k Number | K041718 |
| Device Name: | KELES FACEMASK |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Contact | Dave Graver |
| Correspondent | Dave Graver GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-24 |
| Decision Date | 2004-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8282200180 | K041718 | 000 |