The following data is part of a premarket notification filed by Ssl Americas with the FDA for Durex Play Tingling Aqueous Based Lubricant.
Device ID | K072236 |
510k Number | K072236 |
Device Name: | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT |
Classification | Lubricant, Personal |
Applicant | SSL AMERICAS 3585 ENGINEERING DR. Norcross, GA 30092 |
Contact | Chris Robinson |
Correspondent | Chris Robinson SSL AMERICAS 3585 ENGINEERING DR. 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 | 2007-08-10 |
Decision Date | 2008-05-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20067981934438 | K072236 | 000 |
10067981963493 | K072236 | 000 |