Device Classification Name |
apparatus, suction, ward use, portable, ac-powered
|
510(k) Number |
K112421 |
Device Name |
EMG SUCTION UNIT |
Applicant |
EMG TECHNOLOGY CO., LTD. |
NO.58, 35 RD, TAICHUNG |
INDUSTRIAL PARK, SHITUEN CHIU |
TAICHUNG,
TW
40768
|
|
Applicant Contact |
PAUL CHO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/23/2011 |
Decision Date | 09/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|