Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K100218 |
Device Name |
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
REBEKA STOLTMAN |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
REBEKA STOLTMAN |
Classification Product Code |
|
Date Received | 01/26/2010 |
Decision Date | 02/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|