The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 4 Series Phototherapy Unit Model 4 Series.
Device ID | K111172 |
510k Number | K111172 |
Device Name: | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
Contact | Michele Thiel |
Correspondent | Michele Thiel DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-26 |
Decision Date | 2011-08-29 |
Summary: | summary |