The following data is part of a premarket notification filed by Westridge Laboratories Inc. with the FDA for I-d Glide.
Device ID | K051295 |
510k Number | K051295 |
Device Name: | I-D GLIDE |
Classification | Lubricant, Personal |
Applicant | WESTRIDGE LABORATORIES INC. PO BOX 4341 Crofton, MD 21114 |
Contact | Yolanda Smith |
Correspondent | Yolanda Smith WESTRIDGE LABORATORIES INC. PO BOX 4341 Crofton, MD 21114 |
Product Code | NUC |
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 | 2006-02-15 |
Summary: | summary |