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 Instrument, Biopsy
510(k) Number K152989
Device Name Mammotome revolve Dual Vacuum Assist Biopsy System
Applicant
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati,  OH  45241
Applicant Contact SHAWNA M. ROSE
Correspondent
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati,  OH  45241
Correspondent Contact SHAWNA M. ROSE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/13/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-