The following data is part of a premarket notification filed by Pharmapac Llc with the FDA for Warming Liquid Personal Lubricant.
Device ID | K052974 |
510k Number | K052974 |
Device Name: | WARMING LIQUID 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 | 2005-10-24 |
Decision Date | 2005-12-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00084579128587 | K052974 | 000 |
50050428539519 | K052974 | 000 |