The following data is part of a premarket notification filed by Mcneil-ppc, Inc. with the FDA for K-y Brand Intrigue Intense Warming Sensation.
Device ID | K072360 |
510k Number | K072360 |
Device Name: | K-Y BRAND INTRIGUE INTENSE WARMING SENSATION |
Classification | Lubricant, Personal |
Applicant | MCNEIL-PPC, INC. 199 Grandview Road Skillman, NJ 08558 |
Contact | Nader Fotouhu, Ph.d. |
Correspondent | Nader Fotouhu, Ph.d. MCNEIL-PPC, INC. 199 Grandview Road 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 | 2007-08-22 |
Decision Date | 2007-12-12 |
Summary: | summary |