The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for K-y Lubricating Jelly.
| Device ID | K780386 |
| 510k Number | K780386 |
| Device Name: | K-Y LUBRICATING JELLY |
| Classification | Jelly, Lubricating, For Transurethral Surgical Instrument |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | FHX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-10 |
| Decision Date | 1978-04-13 |