The following data is part of a premarket notification filed by Wisconsin Pharmacal Co., Llc with the FDA for Warming Jelly Personal Lubricant.
| Device ID | K123770 |
| 510k Number | K123770 |
| Device Name: | WARMING JELLY PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | WISCONSIN PHARMACAL CO., LLC 1 PHARMACAL WAY Jackson, WI 53037 |
| Contact | John Nygaard |
| Correspondent | John Nygaard WISCONSIN PHARMACAL CO., LLC 1 PHARMACAL WAY Jackson, WI 53037 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-04-09 |
| Summary: | summary |