• 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 material, impression
510(k) Number K113263
Device Name ARGES IMAGING CONTRAST SPRAY
Applicant
ARGES IMAGING, INC
129 north hill avenue
pasadena,  CA  91106
Applicant Contact rebecca k pine
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/04/2011
Decision Date 11/14/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-