Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K061919 |
Device Name |
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM |
Applicant |
BLUE SKY MEDICAL GROUP INCORPORATED |
5924 BALFOUR CT. |
SUITE 102 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
JASPER BENKE |
Correspondent |
BLUE SKY MEDICAL GROUP INCORPORATED |
5924 BALFOUR CT. |
SUITE 102 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
JASPER BENKE |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 07/06/2006 |
Decision Date | 02/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|