Device Classification Name |
apparatus, suction, ward use, portable, ac-powered
|
510(k) Number |
K181398 |
Device Name |
DV-300 Aspirator |
Applicant |
Ding Hwa Co., Ltd. |
No. 121, Sec. 3, Zhongshan Rd. |
Dacun,
TW
51542
|
|
Applicant Contact |
Eric Han |
Correspondent |
V2K Medical, Inc. |
1221 Innsbruck Drive |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
John MacMahon |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 05/29/2018 |
Decision Date | 07/23/2018 |
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
|
|
|