The following data is part of a premarket notification filed by Halozyme Therapeutics Inc. with the FDA for Cumulase.
| Device ID | K042495 |
| 510k Number | K042495 |
| Device Name: | CUMULASE |
| Classification | Media, Reproductive |
| Applicant | HALOZYME THERAPEUTICS INC. 11588 SORRENTO VALLEY RD. #17 San Diego, CA 92121 |
| Contact | Don Kennard |
| Correspondent | Don Kennard HALOZYME THERAPEUTICS INC. 11588 SORRENTO VALLEY RD. #17 San Diego, CA 92121 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-14 |
| Decision Date | 2005-04-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CUMULASE 78404403 3061136 Live/Registered |
HALOZYME, INC. 2004-04-19 |