Device Classification Name |
lubricant, personal
|
510(k) Number |
K211967 |
Device Name |
Sensual Massage, Ultra Pure |
Applicant |
Dreambrands, Inc. |
11645 N. Cave Creek Road |
Phoenix,
AZ
85020
|
|
Applicant Contact |
Cecile Kehoe |
Correspondent |
Wagoner Consulting LLG |
PO Box 15729 |
Wilmington,
NC
28408
|
|
Correspondent Contact |
Cheryl Wagoner |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/24/2021 |
Decision Date | 11/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|