The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Play Warmer Lubricant.
| Device ID | K042563 |
| 510k Number | K042563 |
| Device Name: | DUREX PLAY WARMER LUBRICANT |
| Classification | Lubricant, Patient |
| 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 | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-21 |
| Decision Date | 2005-02-23 |
| Summary: | summary |