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 bougie, esophageal, ent
510(k) Number K844169
Device Name VOLUMATIC
Applicant
GLAXO, INC.
5 MOORE DR.
P.O. BOX 13358
RESEARCH TRIANGLE,  NC  27709
Applicant Contact DAVID MACFARLANE
Correspondent
GLAXO, INC.
5 MOORE DR.
P.O. BOX 13358
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact DAVID MACFARLANE
Regulation Number874.4420
Classification Product Code
KCD  
Date Received10/25/1984
Decision Date 11/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-