Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K080620 |
Device Name |
MODIFICATION TO 3M TEGADERM CHG DRESSING |
Applicant |
3M COMPANY-3M HEALTH CARE |
3M CENTER, BLDG. 275-5W-06 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
MARIA RUIZ |
Correspondent |
3M COMPANY-3M HEALTH CARE |
3M CENTER, BLDG. 275-5W-06 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
MARIA RUIZ |
Classification Product Code |
|
Date Received | 03/04/2008 |
Decision Date | 05/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|