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 |