The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Smart Touch Uvtherapy Multiple Machine.
| Device ID | K110912 |
| 510k Number | K110912 |
| Device Name: | SMART TOUCH UVTHERAPY MULTIPLE MACHINE |
| 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 | 2011-04-01 |
| Decision Date | 2011-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280861PH4800MMPC60 | K110912 | 000 |
| B2809801MI0010MMPC6 | K110912 | 000 |
| B2809801MI0604MMPC6 | K110912 | 000 |
| B2809801MI1000MMPC5 | K110912 | 000 |
| B2809801MI1000MMPC6 | K110912 | 000 |
| B2809861PH0048MMPC6 | K110912 | 000 |
| B2809861PH2424MMPC6 | K110912 | 000 |
| B2809861PH4800MMPC6 | K110912 | 000 |
| B2809862NL0040MMPCT3 | K110912 | 000 |
| B280801MI0010MMPC60 | K110912 | 000 |
| B280801MI0604MMPC60 | K110912 | 000 |
| B280801MI1000MMPC60 | K110912 | 000 |
| B280803MI0604MMPC60 | K110912 | 000 |
| B280861PH0024MMPC60 | K110912 | 000 |
| B280861PH0048MMPC60 | K110912 | 000 |
| B280861PH2424MMPC60 | K110912 | 000 |
| B2809801MI0010MMPC5 | K110912 | 000 |