The following data is part of a premarket notification filed by Sage Biopharma with the FDA for 1.5 M Propanediol Freezing Medium, 1.5 Propanediol 0.1 Sucrose Freezing Medium, 9% Glycerol, 0.2 M Sucrose Freezing Medi.
| Device ID | K991390 |
| 510k Number | K991390 |
| Device Name: | 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI |
| Classification | Media, Reproductive |
| Applicant | SAGE BIOPHARMA 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland SAGE BIOPHARMA 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 2000-01-18 |