The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 1 Series Phototherapy Equipment.
Device ID | K220840 |
510k Number | K220840 |
Device Name: | 1 Series Phototherapy Equipment |
Classification | Light, Ultraviolet, Dermatological |
Applicant | Daavlin Distributing Co. 205 West Bement Street Bryan, OH 43506 |
Contact | Michele Thiel |
Correspondent | Michele Thiel Daavlin Distributing Co. 205 West Bement Street Bryan, OH 43506 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-23 |
Decision Date | 2022-04-22 |