The following data is part of a premarket notification filed by Pharmapac Llc with the FDA for Pharmapac Lubricating Jelly.
| Device ID | K070623 |
| 510k Number | K070623 |
| Device Name: | PHARMAPAC LUBRICATING JELLY |
| 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 | 2007-03-06 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50311917185557 | K070623 | 000 |
| 50681131034802 | K070623 | 000 |
| 00084579128570 | K070623 | 000 |
| 00504284462702 | K070623 | 000 |
| 00504281471226 | K070623 | 000 |
| 00504281274698 | K070623 | 000 |
| 10894025001732 | K070623 | 000 |
| 00022600000020 | K070623 | 000 |
| 00022600000013 | K070623 | 000 |