Device Classification Name |
lubricant, personal
|
510(k) Number |
K150397 |
Device Name |
Divine 9 |
Applicant |
CarraShield Labs, Inc. |
8815 Conroy Road |
Orlando,
FL
32835
|
|
Applicant Contact |
Dean Fresonke |
Correspondent |
O'Connell Regulatory Consultants, Inc. |
5 Timber Lane |
North Reading,
MA
01864
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 11/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|