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 K904987
Device Name VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
Applicant
Vibronics
401 S. Hartz Ave.
Suite 301
Danville,  CA  94526
Applicant Contact RICHARD TERWILLIGER
Correspondent
Vibronics
401 S. Hartz Ave.
Suite 301
Danville,  CA  94526
Correspondent Contact RICHARD TERWILLIGER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/07/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-