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 |