Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K951914 |
Device Name |
HYDRACARE ABSORBENT WOUND DRESSING |
Applicant |
ACACIA LABORATORIES, INC. |
1719 SOUTH GRAND AVE. |
SANTA ANA,
CA
92705 -4808
|
|
Applicant Contact |
PHILIP L RITGER |
Correspondent |
ACACIA LABORATORIES, INC. |
1719 SOUTH GRAND AVE. |
SANTA ANA,
CA
92705 -4808
|
|
Correspondent Contact |
PHILIP L RITGER |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 04/24/1995 |
Decision Date | 05/15/1995 |
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
|
|
|