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 needle, aspiration and injection, reusable
510(k) Number K862481
Device Name CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
418 B AVE.
KALONA,  IA  52247
Applicant Contact VICTOR WEDEL
Correspondent
CIVCO MEDICAL INSTRUMENTS CO., INC.
418 B AVE.
KALONA,  IA  52247
Correspondent Contact VICTOR WEDEL
Regulation Number878.4800
Classification Product Code
GDM  
Date Received06/30/1986
Decision Date 07/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-