The following data is part of a premarket notification filed by Topco Sales with the FDA for Walgreen's Personal Lubricating Jelly.
Device ID | K080978 |
510k Number | K080978 |
Device Name: | WALGREEN'S PERSONAL LUBRICATING JELLY |
Classification | Lubricant, Personal |
Applicant | TOPCO SALES 9401 DE SOTO AVE. Chatsworth, CA 91311 |
Contact | Lorelei Chavez |
Correspondent | Lorelei Chavez TOPCO SALES 9401 DE SOTO AVE. Chatsworth, CA 91311 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-07 |
Decision Date | 2009-04-23 |
Summary: | summary |