The following data is part of a premarket notification filed by Personal Products Co. with the FDA for K-y Brand Intrigue.
Device ID | K062796 |
510k Number | K062796 |
Device Name: | K-Y BRAND INTRIGUE |
Classification | Lubricant, Personal |
Applicant | PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
Contact | Nader Fotouhi |
Correspondent | Nader Fotouhi PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-19 |
Decision Date | 2006-12-08 |
Summary: | summary |