The following data is part of a premarket notification filed by Sage Biopharma with the FDA for Hyaluronidase, 80 U/ml.
| Device ID | K991393 |
| 510k Number | K991393 |
| Device Name: | HYALURONIDASE, 80 U/ML |
| 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 | 2000-02-02 |