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 |