The following data is part of a premarket notification filed by Sheffield Laboratories, Div. Of Faria Limited, Llc with the FDA for Sheffield Brand Warming Lubrigel Personal Lubricant.
| Device ID | K052162 |
| 510k Number | K052162 |
| Device Name: | SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC 170 BROAD ST. New London, CT 06320 |
| Contact | Kathleen Hacku |
| Correspondent | Kathleen Hacku SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC 170 BROAD ST. New London, CT 06320 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2006-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917202423 | K052162 | 000 |