The following data is part of a premarket notification filed by Nidacon International Ab with the FDA for Puresperm.
| Device ID | K980814 |
| 510k Number | K980814 |
| Device Name: | PURESPERM |
| 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 | 1998-03-03 |
| Decision Date | 1998-06-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PURESPERM 75260856 not registered Dead/Abandoned |
NidaCon Laboratories AB 1997-03-20 |
![]() PURESPERM 75201832 2143591 Dead/Cancelled |
SCANDINAVIAN IVF SCIENCE USA, INC. 1996-11-19 |