The following data is part of a premarket notification filed by Haselmeier Sarl with the FDA for Haselmeier Pen.
| Device ID | K070100 |
| 510k Number | K070100 |
| Device Name: | HASELMEIER PEN |
| Classification | Syringe, Piston |
| Applicant | HASELMEIER SARL 517 BENFIELD ROAD SUITE 301 Severna Park, MD 21146 -2596 |
| Contact | Melissa Mahall |
| Correspondent | Melissa Mahall HASELMEIER SARL 517 BENFIELD ROAD SUITE 301 Severna Park, MD 21146 -2596 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-10 |
| Decision Date | 2007-03-21 |
| Summary: | summary |