• 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 neurosurgical paddie
510(k) Number K121822
Model 63-01 THROUGH 63-10
Device Name DELICOT
Original Applicant
AMERICAN SURGICAL COMPANY, LLC
82 sanderson avenue
lynn,  MA  01902
Original Contact erik piasio
Regulation Number882.4700
Classification Product Code
HBA  
Date Received06/21/2012
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-