Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K122634 |
Device Name |
IODOFOAM IODOPHOR FOAM DRESSING |
Applicant |
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC |
150 LEVINBERG LANE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
MASON DIAMOND |
Correspondent |
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC |
150 LEVINBERG LANE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
MASON DIAMOND |
Classification Product Code |
|
Date Received | 08/29/2012 |
Decision Date | 03/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|