Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K153459
Device Name TACVAC
Applicant
Athena Gtx
5900 NW 86th St.
Suite 300
Johnson,  IA  50131
Applicant Contact SEAN MAHONEY
Correspondent
Athena Gtx
5900 NW 86th St.
Suite 300
Johnson,  IA  50131
Correspondent Contact SEAN MAHONEY
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/01/2015
Decision Date 01/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-