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 |