The following data is part of a premarket notification filed by Medicult A/s with the FDA for Medi-cult Acidified Tyrodes Solution- Medium; Internal Catalog Numbers (1060).
| Device ID | K991470 |
| 510k Number | K991470 |
| Device Name: | MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) |
| 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 | 1999-04-14 |
| Decision Date | 2000-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937817373 | K991470 | 000 |