Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K122490 |
Device Name |
KULAVAC |
Applicant |
CGBIO CO., LTD |
163-3 SAMSUNG-DONG |
KANGNAM-GU |
SEOUL,
KR
135-715
|
|
Applicant Contact |
JUNGEUN IM |
Correspondent |
CGBIO CO., LTD |
163-3 SAMSUNG-DONG |
KANGNAM-GU |
SEOUL,
KR
135-715
|
|
Correspondent Contact |
JUNGEUN IM |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/15/2012 |
Decision Date | 11/13/2013 |
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
|