The following data is part of a premarket notification filed by Nidacon International Ab with the FDA for Puresperm 40 And Puresperm 80.
| Device ID | K002623 |
| 510k Number | K002623 |
| Device Name: | PURESPERM 40 AND PURESPERM 80 |
| Classification | Media, Reproductive |
| Applicant | NIDACON INTERNATIONAL AB P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NIDACON INTERNATIONAL AB P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2000-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025610399 | K002623 | 000 |
| 07350025610092 | K002623 | 000 |
| 07350025610023 | K002623 | 000 |
| 07350025610016 | K002623 | 000 |
| 07350025610009 | K002623 | 000 |