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 |