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 General Surgery Tray
510(k) Number K030721
Device Name QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact CINDY ELLIS
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact CINDY ELLIS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received03/07/2003
Decision Date 03/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-