The following data is part of a premarket notification filed by Wtfn-dba Classic Erotica/holiday Products with the FDA for Just Like Me Personal Lubricant.
Device ID | K161385 |
510k Number | K161385 |
Device Name: | Just Like Me Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | WTFN-dba Classic Erotica/Holiday Products 20950 Lassen Street Chatsworth, CA 91311 |
Contact | Christina Zaragoza |
Correspondent | Louie Goryoka Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-19 |
Decision Date | 2016-08-17 |
Summary: | summary |