The following data is part of a premarket notification filed by Cst Medical Limited with the FDA for Vielle Lubricant.
| Device ID | K051288 |
| 510k Number | K051288 |
| Device Name: | VIELLE LUBRICANT |
| Classification | Condom |
| Applicant | CST MEDICAL LIMITED 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | Christian Smith |
| Correspondent | Christian Smith CST MEDICAL LIMITED 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2006-02-03 |
| Summary: | summary |