Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K082330 |
Device Name |
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
Applicant |
PRIMARY CARE SOLUTIONS, INC. |
40420 FREE FALL AVE. |
ZEPHYRHILLS,
FL
33542
|
|
Applicant Contact |
RON MADDIX |
Correspondent |
PRIMARY CARE SOLUTIONS, INC. |
40420 FREE FALL AVE. |
ZEPHYRHILLS,
FL
33542
|
|
Correspondent Contact |
RON MADDIX |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/14/2008 |
Decision Date | 10/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|