Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K121522 |
Device Name |
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) |
Applicant |
POLYREMEDY, INC. |
49 COASTAL OAK |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
GARY MOCNIK |
Correspondent |
POLYREMEDY, INC. |
49 COASTAL OAK |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
GARY MOCNIK |
Classification Product Code |
|
Date Received | 05/23/2012 |
Decision Date | 06/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|