The following data is part of a premarket notification filed by Medicult A/s with the FDA for Medi-cult Sperm Preparation - Medium;.
| Device ID | K991332 |
| 510k Number | K991332 |
| Device Name: | MEDI-CULT SPERM PREPARATION - MEDIUM; |
| Classification | Media, Reproductive |
| Applicant | MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 2000-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937829390 | K991332 | 000 |
| 20888937817403 | K991332 | 000 |
| 20888937800856 | K991332 | 000 |
| 00888937800791 | K991332 | 000 |
| 00888937800708 | K991332 | 000 |
| 00888937030372 | K991332 | 000 |
| 00888937030358 | K991332 | 000 |
| 60888937029309 | K991332 | 000 |
| 60888937029262 | K991332 | 000 |