Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K133333 |
FOIA Releasable 510(k) |
K133333
|
Device Name |
UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT |
Applicant |
BLUE OCEAN MEDICAL PRODUCT, LLC. |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
BLUE OCEAN MEDICAL PRODUCT, LLC. |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/29/2013 |
Decision Date | 12/31/2014 |
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
|