The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Sterile Lubricating Jelly.
| Device ID | K092488 |
| 510k Number | K092488 |
| Device Name: | DYNAREX STERILE LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | Daniel Consaga |
| Correspondent | Daniel Consaga DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2009-12-18 |
| Summary: | summary |