Device Classification Name |
Brush, Endometrial
|
510(k) Number |
K112763 |
Device Name |
MATRIXBRUSH ENDOMETRIAL SAMPLER |
Applicant |
POST OAK INNOVATIONS, INC. |
9433 BEE CAVES ROAD |
BUILDING 1, SUITE 140 |
AUSTIN,
TX
78733
|
|
Applicant Contact |
HEATHER CRAWFORD |
Correspondent |
POST OAK INNOVATIONS, INC. |
9433 BEE CAVES ROAD |
BUILDING 1, SUITE 140 |
AUSTIN,
TX
78733
|
|
Correspondent Contact |
HEATHER CRAWFORD |
Regulation Number | 884.1100
|
Classification Product Code |
|
Date Received | 09/22/2011 |
Decision Date | 06/18/2012 |
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
|
|
|