The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Pen P100.
| Device ID | K993666 |
| 510k Number | K993666 |
| Device Name: | DISETRONIC PEN P100 |
| Classification | Syringe, Piston |
| Applicant | DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers, FL 33912 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 1999-11-22 |
| Summary: | summary |