The following data is part of a premarket notification filed by Haselmeier Gmbh with the FDA for Tactipen.
Device ID | K083457 |
510k Number | K083457 |
Device Name: | TACTIPEN |
Classification | Syringe, Piston |
Applicant | HASELMEIER GMBH 30833 NORTHWESTERN HIGHWAY SUITE 121 Farmington Hill, MI 48334 |
Contact | Stephen J Goldner, Jd, Rac |
Correspondent | Stephen J Goldner, Jd, Rac HASELMEIER GMBH 30833 NORTHWESTERN HIGHWAY SUITE 121 Farmington Hill, MI 48334 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-21 |
Decision Date | 2009-02-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TACTIPEN 85622180 4264408 Dead/Cancelled |
Hoechst GmbH 2012-05-10 |
![]() TACTIPEN 78094273 3019543 Dead/Cancelled |
HOECHST GMBH 2001-11-20 |