The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Se.
Device ID | K070254 |
510k Number | K070254 |
Device Name: | HORIZON SE |
Classification | Computer, Diagnostic, Programmable |
Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST. P.O. BOX 102 REHOVOT Yavne, IL 76100 |
Contact | Micha Oestereich |
Correspondent | Micha Oestereich MENNEN MEDICAL LTD. 4 HAYARDEN ST. P.O. BOX 102 REHOVOT Yavne, IL 76100 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-26 |
Decision Date | 2007-04-19 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HORIZON SE 78542645 3152907 Dead/Cancelled |
Mennen Medical Corp. 2005-01-05 |