The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Adaptable Class Iii Mask.
| Device ID | K861424 |
| 510k Number | K861424 |
| Device Name: | ADAPTABLE CLASS III MASK |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Contact | Vickie Ploscyca |
| Correspondent | Vickie Ploscyca GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. 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 | 1986-04-16 |
| Decision Date | 1986-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7751551220 | K861424 | 000 |
| D7751551210 | K861424 | 000 |