The following data is part of a premarket notification filed by Medicult A/s with the FDA for Synvitro Hyadase.
| Device ID | K031228 |
| 510k Number | K031228 |
| Device Name: | SYNVITRO HYADASE |
| 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 | 2003-04-18 |
| Decision Date | 2003-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937817960 | K031228 | 000 |