The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Head Strap.
| Device ID | K831008 |
| 510k Number | K831008 |
| Device Name: | HEAD STRAP |
| Classification | Strap, Head, Gas Mask |
| Applicant | MEDOVATIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTK |
| CFR Regulation Number | 868.5560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-30 |
| Decision Date | 1983-05-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEAD STRAP 98389237 not registered Live/Pending |
Ke, Hongxia 2024-02-02 |