The following data is part of a premarket notification filed by Lelo Inc. with the FDA for Lelo Hex Natural Rubber Latex Condom.
| Device ID | K160644 |
| 510k Number | K160644 |
| Device Name: | Lelo 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350075029578 | K160644 | 000 |
| 07350075025075 | K160644 | 000 |
| 07350075022494 | K160644 | 000 |
| 07350075022470 | K160644 | 000 |