The following data is part of a premarket notification filed by Lelo Inc. with the FDA for Lelo Respect Hex Natural Rubber Latex Condom.
| Device ID | K162511 |
| 510k Number | K162511 |
| Device Name: | LELO RESPECT HEX Natural Rubber Latex Condom |
| Classification | Condom |
| Applicant | LELO INC. 4320 STEVENS CREEK BLVD., SUITE 205 San Jose, CA 95129 |
| Contact | Pavle Sedic |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 GOLDEN EAGLE LANE Littleton, CO 80127 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-08 |
| Decision Date | 2017-01-13 |