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 |