The following data is part of a premarket notification filed by Newmed Corp. with the FDA for Doser.
Device ID | K935955 |
510k Number | K935955 |
Device Name: | DOSER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | NEWMED CORP. 740 MAIN STREET, SUITE 107 Waltham, MA 02154 |
Contact | Debbie Iampietro |
Correspondent | Debbie Iampietro NEWMED CORP. 740 MAIN STREET, SUITE 107 Waltham, MA 02154 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-13 |
Decision Date | 1994-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DOSER 75059265 2120870 Live/Registered |
MEDITRACK PRODUCTS, LLC 1996-02-16 |
DOSER 74662298 not registered Dead/Abandoned |
New-Med Corporation 1995-04-17 |
DOSER 74487665 not registered Dead/Abandoned |
New-Med Corporation 1994-02-07 |
DOSER 73641537 not registered Dead/Abandoned |
ARES SERONO NV, AMSTERDAM, SUCCURSALE DE GENEVE 1987-01-28 |