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 K022029
Device Name QUINCKE SPINAL NEEDLE
Applicant
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Applicant Contact CHRISTOPHER B LAKE
Correspondent
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Correspondent Contact CHRISTOPHER B LAKE
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/21/2002
Decision Date 07/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-