The following data is part of a premarket notification filed by Gac Intl., Inc. with the FDA for Gac Thumb-sucking Control Appliance.
| Device ID | K920850 |
| 510k Number | K920850 |
| Device Name: | GAC THUMB-SUCKING CONTROL APPLIANCE |
| Classification | Wire, Orthodontic |
| Applicant | GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722 |
| Contact | Ernest Bohn |
| Correspondent | Ernest Bohn GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-08-24 |