The following data is part of a premarket notification filed by Companion Medical, Inc. with the FDA for Inpen.
| Device ID | K160629 |
| 510k Number | K160629 |
| Device Name: | InPen |
| Classification | Syringe, Piston |
| Applicant | COMPANION MEDICAL, INC. 16486 BERNARDO CENTER, DRIVE SUITE 300 San Diego, CA 92128 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke COMPANION MEDICAL, INC. 16486 BERNARDO CENTER, DRIVE SUITE 300 San Diego, CA 92128 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-07-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INPEN 87349386 not registered Live/Pending |
Companion medical, Inc. 2017-02-24 |
![]() INPEN 86679108 4942959 Live/Registered |
Companion Medical Inc. 2015-06-30 |