The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Penfine Injection Pen Needle.
| Device ID | K982399 |
| 510k Number | K982399 |
| Device Name: | DISETRONIC PENFINE INJECTION PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Contact | Patrik De Haes |
| Correspondent | Patrik De Haes DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-08-06 |
| Summary: | summary |