The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Ml24000 Uva-1 Phototherapy Cabinet.
Device ID | K151795 |
510k Number | K151795 |
Device Name: | ML24000 UVA-1 Phototherapy Cabinet |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-02 |
Decision Date | 2015-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B280935ML24000PC0 | K151795 | 000 |