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 biopsy needle
510(k) Number K950982
Device Name B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
Applicant
B. BRAUN OF AMERICA, INC.
824 12TH AVE.
BETHLEHEM,  PA  18018
Applicant Contact JONAS D WILF
Correspondent
B. BRAUN OF AMERICA, INC.
824 12TH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact JONAS D WILF
Regulation Number876.1075
Classification Product Code
FCG  
Date Received03/03/1995
Decision Date 04/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-