• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name drape, surgical
510(k) Number K121436
Device Name DAS MEDICAL EQUIPMENT DRAPES
Original Applicant
DAS MEDICAL, LLC
100 rosecrest lane
columbus,  MS  39701
Original Contact armond groves
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/15/2012
Decision Date 06/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-