The following data is part of a premarket notification filed by Sion Biotext Medical Ltd with the FDA for Lubricating Jelly.
| Device ID | K142473 |
| 510k Number | K142473 |
| Device Name: | Lubricating Jelly |
| Classification | Lubricant, Patient |
| Applicant | SION BIOTEXT MEDICAL LTD KIBBUTZ HAGOSHRIM Upper Galilee, IL 12225 |
| Contact | Nadav Reuben |
| Correspondent | Tali Hazan TALMED LTD M.P UPPER GALILEE Ramot Naftali, IL 1383000 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-04-13 |
| Summary: | summary |