The following data is part of a premarket notification filed by Origio A/s with the FDA for Medicult Vitrification Cooling/warming, Model Ref: 1228, 1229.
| Device ID | K100367 |
| 510k Number | K100367 |
| Device Name: | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 |
| Classification | Media, Reproductive |
| Applicant | ORIGIO A/S 9915 CAM, CHIRIMOLLA San Diego, CA 92131 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi ORIGIO 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 | 2010-02-12 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937801783 | K100367 | 000 |
| 60888937801745 | K100367 | 000 |