Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K063671 |
Device Name |
REBOUND HRD |
Applicant |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/11/2006 |
Decision Date | 08/16/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|