The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Play Temptations Assorted Lubricants.
Device ID | K060098 |
510k Number | K060098 |
Device Name: | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-13 |
Decision Date | 2006-06-08 |
Summary: | summary |