The following data is part of a premarket notification filed by United Consortium Inc. with the FDA for Jo H20 Water Based Personal Lubricant.
Device ID | K150480 |
510k Number | K150480 |
Device Name: | JO H20 Water Based Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | UNITED CONSORTIUM INC. 29000 HANCOCK PKWY Valencia, CA 91355 |
Contact | Joe Mendoza |
Correspondent | Joe Mendoza UNITED CONSORTIUM Inc. 29000 HANCOCK PKWY Valencia, CA 91355 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-24 |
Decision Date | 2015-07-08 |
Summary: | summary |