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 Arterial Blood Sampling Kit
510(k) Number K954015
Device Name ABG POINT LOK NEEDLE PROTECTION DEVICE
Applicant
Devon Industries, Inc.
9530 Desoto Ave.
Chatsworth,  CA  91311 -5084
Applicant Contact GEORGE AUSTRIA
Correspondent
Devon Industries, Inc.
9530 Desoto Ave.
Chatsworth,  CA  91311 -5084
Correspondent Contact GEORGE AUSTRIA
Regulation Number868.1100
Classification Product Code
CBT  
Date Received08/25/1995
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-