The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disentronic Penfine Injection Pen Needle.
Device ID | K994197 |
510k Number | K994197 |
Device Name: | DISENTRONIC PENFINE INJECTION PEN NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
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 | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-13 |
Decision Date | 1999-12-29 |
Summary: | summary |