Device Classification Name |
clamp, circumcision
|
510(k) Number |
K221356 |
Device Name |
Wee Bell |
Applicant |
wee MEDICAL |
6800 Baum Drive |
Knoxville,,
TN
37919
|
|
Applicant Contact |
D Preston Smith |
Correspondent |
Grace Powers - Powers Regulatory Consulting |
2451 Cumberland Parkway SE, Suite 3740 |
Atlanta,
GA
30339
|
|
Correspondent Contact |
Grace Powers |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/10/2022 |
Decision Date | 02/02/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|