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 K871467
Device Name BIOPSY NEEDLE GUIDE KIT, STERILE
Applicant
Amedic USA
3702 E. Roeser Rd., Ste
27,P.O.B.62404
Phoenix,  AZ  85040 -3969
Applicant Contact JACK A MOORE
Correspondent
Amedic USA
3702 E. Roeser Rd., Ste
27,P.O.B.62404
Phoenix,  AZ  85040 -3969
Correspondent Contact JACK A MOORE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/14/1987
Decision Date 08/21/1987
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
-
-