• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name apparatus, suction, ward use, portable, ac-powered
510(k) Number K181398
Device Name DV-300 Aspirator
Ding Hwa Co., Ltd.
No. 121, Sec. 3, Zhongshan Rd.
Dacun,  TW 51542
Applicant Contact Eric Han
V2K Medical, Inc.
1221 Innsbruck Drive
Sunnyvale,  CA  94089
Correspondent Contact John MacMahon
Regulation Number878.4780
Classification Product Code
Date Received05/29/2018
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