The following data is part of a premarket notification filed by Daavlin Distributing Company with the FDA for 3 Series Phototherapy Unit.
Device ID | K153749 |
510k Number | K153749 |
Device Name: | 3 Series Phototherapy Unit |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN DISTRIBUTING COMPANY 205 WEST BEMENT STREET Bryan, OH 43506 |
Contact | Michele Thiel |
Correspondent | Michele Thiel DAAVLIN DISTRIBUTING COMPANY 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 | 2015-12-29 |
Decision Date | 2016-06-30 |
Summary: | summary |