The following data is part of a premarket notification filed by Autovage with the FDA for Endo-ject.
Device ID | K840943 |
510k Number | K840943 |
Device Name: | ENDO-JECT |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | AUTOVAGE 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-05 |
Decision Date | 1984-05-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENDO-JECT 73580734 1407579 Dead/Cancelled |
RUDOLPH, JOSEPH P. 1986-02-03 |