Device Classification Name |
perineometer
|
510(k) Number |
K133990 |
Device Name |
IEVA REHABILITATIVE POSITIONAL DEVICE |
Applicant |
REMENDIUM LABS, LLC |
340 EAST PARKER ROAD |
BATON ROUGE,
LA
70803
|
|
Applicant Contact |
YOLANDA LORIE |
Correspondent |
REMENDIUM LABS, LLC |
340 EAST PARKER ROAD |
BATON ROUGE,
LA
70803
|
|
Correspondent Contact |
YOLANDA LORIE |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 12/27/2013 |
Decision Date | 10/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|