Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K210751 |
Device Name |
S.E.A.L. Hemostatic Wound Spray |
Applicant |
BC3 Technologies Inc |
3701-A Southwestern Blvd |
Baltimore,
MD
21229
|
|
Applicant Contact |
Wayne L. Grube |
Correspondent |
BC3 Technologies Inc |
3701-A Southwestern Blvd |
Baltimore,
MD
21229
|
|
Correspondent Contact |
Wayne L. Grube |
Classification Product Code |
|
Date Received | 03/12/2021 |
Decision Date | 02/02/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|