The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Play Tingling Lubricant.
| Device ID | K042958 |
| 510k Number | K042958 |
| Device Name: | DUREX PLAY TINGLING LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Contact | Chris Robinson |
| Correspondent | Chris Robinson SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-10-27 |
| Decision Date | 2005-04-08 |
| Summary: | summary |