The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal Lubricating Jelly.
| Device ID | K113689 |
| 510k Number | K113689 |
| Device Name: | DUKAL LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | DUKAL CORPORATION 2 FLEETWOOD CT Ronkonkoma, NY 11779 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb DUKAL CORPORATION 2 FLEETWOOD CT Ronkonkoma, NY 11779 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-05-04 |
| Summary: | summary |