Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K120828 |
Device Name |
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES |
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 | 03/19/2012 |
Decision Date | 04/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|