Device Classification Name |
hemostatic wound dressing without thrombin or other biologics
|
510(k) Number |
K123387 |
Device Name |
QUIKCLOT HEMOSTATIC DRESSING |
Applicant |
Z-MEDICA, LLC |
4 FAIRFIELD BLVD. |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
SHEILA WALLIN |
Correspondent |
Z-MEDICA, LLC |
4 FAIRFIELD BLVD. |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
SHEILA WALLIN |
Classification Product Code |
|
Date Received | 11/02/2012 |
Decision Date | 04/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|