Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K082676 |
Device Name |
GENADYNE A4 WOUND VACUUM SYSTEM |
Applicant |
GENADYNE BIOTECHNOLOGIES, INC. |
65 WATERMILL LANE |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
CHIEN-MING GOH |
Correspondent |
GENADYNE BIOTECHNOLOGIES, INC. |
65 WATERMILL LANE |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
CHIEN-MING GOH |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/15/2008 |
Decision Date | 12/18/2008 |
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
|