Device Classification Name |
hemostatic wound dressing without thrombin or other biologics
|
510(k) Number |
K033291 |
Device Name |
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 |
Applicant |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Applicant Contact |
HELENE EKSTRAND |
Correspondent |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Correspondent Contact |
HELENE EKSTRAND |
Classification Product Code |
|
Date Received | 10/14/2003 |
Decision Date | 03/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|