The following data is part of a premarket notification filed by Sheffield Industries, Div. Of Faria Ltd. with the FDA for Sheffield Pharmaceuticals (sterile) Lubrigel.
| Device ID | K073684 |
| 510k Number | K073684 |
| Device Name: | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL |
| Classification | Lubricant, Patient |
| Applicant | SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. 170 BROAD ST. New London, CT 06320 |
| Contact | Kathleen Hacku |
| Correspondent | Kathleen Hacku SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. 170 BROAD ST. New London, CT 06320 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-05-22 |
| Summary: | summary |