The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Hood Gear (tm) Breakaway Headgear W/ High Pull.
| Device ID | K902645 |
| 510k Number | K902645 |
| Device Name: | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Frances Zee |
| Correspondent | Frances Zee ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-09-06 |