INTRAJECT
Device, Irrigation, Ocular Surgery
GENERAL MEDICAL ENGINEERING CORP.
The following data is part of a premarket notification filed by General Medical Engineering Corp. with the FDA for Intraject.
Pre-market Notification Details
| Device ID | K802332 |
| 510k Number | K802332 |
| Device Name: | INTRAJECT |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | GENERAL MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-12-22 |
Trademark Results [INTRAJECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRAJECT 75012805 2173356 Dead/Cancelled |
ZOGENIX, INC. 1995-10-31 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.