The following data is part of a premarket notification filed by Daavlin Co. with the FDA for 3 Series Phototherapy Cabinet.
| Device ID | K063621 |
| 510k Number | K063621 |
| Device Name: | 3 SERIES PHOTOTHERAPY CABINET |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN CO. 205 WEST BEMENT ST. P.O. BOX 626 Bryan, OH 43506 |
| Contact | Tara Mansur |
| Correspondent | Tara Mansur DAAVLIN CO. 205 WEST BEMENT ST. P.O. BOX 626 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 | 2006-12-05 |
| Decision Date | 2007-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280862PM0048PC60 | K063621 | 000 |
| B280861PH4800SP60 | K063621 | 000 |
| B280861PH4800PC60 | K063621 | 000 |
| B280861PH2424SP60 | K063621 | 000 |
| B280861PH2424PC60 | K063621 | 000 |
| B280861PH0048SP60 | K063621 | 000 |
| B280861PH0048PC60 | K063621 | 000 |
| B280861PH0024SP60 | K063621 | 000 |
| B280861PH0024PC60 | K063621 | 000 |