The following data is part of a premarket notification filed by Haselmeier Gmbh with the FDA for Haselmeier Pen 8.
| Device ID | K082616 |
| 510k Number | K082616 |
| Device Name: | HASELMEIER PEN 8 |
| Classification | Syringe, Piston |
| Applicant | HASELMEIER GMBH 30833 NORTHWESTERN HIGHWAY SUITE 121 Farmington Hill, MI 48334 |
| Contact | Stephen J Goldner |
| Correspondent | Stephen J Goldner HASELMEIER GMBH 30833 NORTHWESTERN HIGHWAY SUITE 121 Farmington Hill, MI 48334 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2008-09-26 |
| Summary: | summary |