The following data is part of a premarket notification filed by Pharmapac Llc with the FDA for Pharmapac Personal Lubricant.
| Device ID | K091554 |
| 510k Number | K091554 |
| Device Name: | PHARMAPAC PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | PHARMAPAC LLC 110 INDUSTRIAL PARK ROAD Dekalb, MS 39329 |
| Contact | Tom Otto |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2009-08-07 |
| Summary: | summary |