Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K941299 |
Device Name |
FLARED PATCH |
Applicant |
FLARED PATCH, INC. |
1101 ST. GREGORY ST. |
CINCINNATI,
OH
45202
|
|
Applicant Contact |
RICHARD L STUDER |
Correspondent |
FLARED PATCH, INC. |
1101 ST. GREGORY ST. |
CINCINNATI,
OH
45202
|
|
Correspondent Contact |
RICHARD L STUDER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/17/1994 |
Decision Date | 08/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|