Device Classification Name |
stent, vaginal
|
510(k) Number |
K202542 |
Device Name |
Allura Vaginal Stent |
Applicant |
PMT Corporation |
1500 Park Road |
Chanhassen,
MN
55317
|
|
Applicant Contact |
Matt Cree |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 884.3900
|
Classification Product Code |
|
Date Received | 09/02/2020 |
Decision Date | 09/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|