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, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K911221
Device Name ATRAUMATIC SPECIAL SPROTTE NEEDLE
Applicant
Pajunk GmbH
Washington Sq., Suite 1100
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact BRUCE MACKLER
Correspondent
Pajunk GmbH
Washington Sq., Suite 1100
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact BRUCE MACKLER
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/19/1991
Decision Date 07/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-