The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 3 Series Phototherapy Cabinet.
Device ID | K042502 |
510k Number | K042502 |
Device Name: | 3 SERIES PHOTOTHERAPY CABINET |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
Contact | David W Swanson |
Correspondent | David W Swanson 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 | 2004-09-14 |
Decision Date | 2004-10-14 |