The following data is part of a premarket notification filed by Personal Products Co., Div. Of Mcneil Ppc, Inc. with the FDA for K-y Brand Warming Liquid Personal Lubricant.
Device ID | K021492 |
510k Number | K021492 |
Device Name: | K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT |
Classification | Lubricant, Personal |
Applicant | PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
Contact | Marylou Panico |
Correspondent | Marylou Panico PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 -9418 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-09 |
Decision Date | 2002-08-07 |
Summary: | summary |