Device Classification Name |
hemostatic wound dressing without thrombin or other biologics
|
510(k) Number |
K180893 |
Device Name |
IHM Technology Bandage |
Applicant |
Protege Biomedical |
10909 Valley View Rd. |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Mike Corcoran |
Correspondent |
Protege Biomedical |
10909 Valley View Rd. |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Mike Corcoran |
Classification Product Code |
|
Date Received | 04/05/2018 |
Decision Date | 09/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|