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 |