The following data is part of a premarket notification filed by Carrashield Labs, Inc. with the FDA for Divine 9.
Device ID | K150397 |
510k Number | K150397 |
Device Name: | Divine 9 |
Classification | Lubricant, Personal |
Applicant | CarraShield Labs, Inc. 8815 Conroy Road Orlando, FL 32835 |
Contact | Dean Fresonke |
Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-18 |
Decision Date | 2015-11-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIVINE 9 85016442 3885931 Live/Registered |
CARRASHIELD LABS, INC. 2010-04-17 |
DIVINE 9 78665839 3681513 Dead/Cancelled |
Atit Diamond Corporation 2005-07-07 |