The following data is part of a premarket notification filed by Nidacon International Ab with the FDA for Vitriblast, Thermoblast, Model Vb-010, Tb-010.
| Device ID | K092107 |
| 510k Number | K092107 |
| Device Name: | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 |
| Classification | Media, Reproductive |
| Applicant | NIDACON INTERNATIONAL AB 333 MILFORD RD Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NIDACON INTERNATIONAL AB 333 MILFORD RD Deerfield, IL 60015 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-07-14 |
| Decision Date | 2010-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025610252 | K092107 | 000 |
| 07350025610245 | K092107 | 000 |