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 Pad, Alcohol, Device Disinfectant
510(k) Number K883840
Device Name DRI-VENT ARTERIAL BLOOD SAMPLING KIT
Applicant
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Classification Product Code
LKB  
Date Received09/12/1988
Decision Date 05/16/1989
Decision Substantially Equivalent - With Drug (SESD)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-