The following data is part of a premarket notification filed by Etex Corporation with the FDA for Etex Mixing And Delivery System.
| Device ID | K141245 |
| 510k Number | K141245 |
| Device Name: | ETEX MIXING AND DELIVERY SYSTEM |
| Classification | Syringe, Piston |
| Applicant | ETEX CORPORATION 675 MASSACHUSETTS AVE 12TH FLOOR Cambridge, MA 02139 |
| Contact | Andy Soman |
| Correspondent | Andy Soman ETEX CORPORATION 675 MASSACHUSETTS AVE 12TH FLOOR Cambridge, MA 02139 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-14 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024563285 | K141245 | 000 |
| 00889024563278 | K141245 | 000 |
| 00889024430082 | K141245 | 000 |
| 00889024205604 | K141245 | 000 |
| 00889024205598 | K141245 | 000 |
| 00889024205581 | K141245 | 000 |
| 00889024205574 | K141245 | 000 |