Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K073663 |
Device Name |
GELSPRAY WOUND DRESSING |
Applicant |
BIOCURE, INC. |
20310 SW 48TH STREET |
SOUTHWEST RANCHES,
FL
33332
|
|
Applicant Contact |
JOHN GREENBAUM |
Correspondent |
BIOCURE, INC. |
20310 SW 48TH STREET |
SOUTHWEST RANCHES,
FL
33332
|
|
Correspondent Contact |
JOHN GREENBAUM |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 12/26/2007 |
Decision Date | 01/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|