The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Pen.
Device ID | K982966 |
510k Number | K982966 |
Device Name: | DISETRONIC PEN |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-25 |
Decision Date | 1998-10-19 |
Summary: | summary |