The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapidvit Blast, Rapidwarm Blast.
| Device ID | K101003 |
| 510k Number | K101003 |
| Device Name: | RAPIDVIT BLAST, RAPIDWARM BLAST |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB BOX 9080 Se-400 92 Goteborg, SE |
| Contact | Kjell Kjork |
| Correspondent | Kjell Kjork VITROLIFE SWEDEN AB BOX 9080 Se-400 92 Goteborg, SE |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-04-12 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025914220 | K101003 | 000 |
| 07350025914213 | K101003 | 000 |