The following data is part of a premarket notification filed by Farco Pharma Gmbh with the FDA for Lubricano Sterile Gel.
| Device ID | K081990 |
| 510k Number | K081990 |
| Device Name: | LUBRICANO STERILE GEL |
| Classification | Jelly, Lubricating, For Transurethral Surgical Instrument |
| Applicant | FARCO PHARMA GMBH 555 ELEVENTH STREET NW Washington, DC 20004 -1304 |
| Contact | Seth A Mailhot |
| Correspondent | Seth A Mailhot FARCO PHARMA GMBH 555 ELEVENTH STREET NW Washington, DC 20004 -1304 |
| Product Code | FHX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-12-05 |
| Summary: | summary |