The following data is part of a premarket notification filed by Endymed Medical Ltd. with the FDA for Endygel.
| Device ID | K161715 |
| 510k Number | K161715 |
| Device Name: | EndyGel |
| Classification | Media, Electroconductive |
| Applicant | EndyMed Medical Ltd. 12 Leshem Street, North Industrial Park Caesarea, IL 3088900 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 30500 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2017-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290016814351 | K161715 | 000 |