Device Classification Name |
bandage, liquid
|
510(k) Number |
K943781 |
Device Name |
ACRYDERM ADVANCED WOUND DRESSING |
Applicant |
ACRYMED, INC. |
31 WALKING WOODS DR. |
LAKE OSWEGO,
OR
97035
|
|
Applicant Contact |
BRUCE L GIBBINS, PH.D |
Correspondent |
ACRYMED, INC. |
31 WALKING WOODS DR. |
LAKE OSWEGO,
OR
97035
|
|
Correspondent Contact |
BRUCE L GIBBINS, PH.D |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 08/03/1994 |
Decision Date | 10/04/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|