The following data is part of a premarket notification filed by Sasmar Inc with the FDA for Conceive Plus.
| Device ID | K131355 |
| 510k Number | K131355 |
| Device Name: | CONCEIVE PLUS |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | SASMAR INC 155 NORTH WACKER DR, STE 4250 Chicago, IL 60606 |
| Contact | John-michael Mancini |
| Correspondent | John-michael Mancini SASMAR INC 155 NORTH WACKER DR, STE 4250 Chicago, IL 60606 |
| Product Code | PEB |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-11-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CONCEIVE PLUS 88110330 5761585 Live/Registered |
MANCINI HOLDINGS PTY LIMITED 2018-09-10 |
![]() CONCEIVE PLUS 85066193 3911176 Live/Registered |
MANCINI HOLDINGS PTY LIMITED 2010-06-18 |