• 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 pump, infusion, elastomeric
510(k) Number K002073
Device Name PAIN CARE 3000
Original Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Original Contact kathleen barber
Regulation Number880.5725
Classification Product Code
MEB  
Date Received07/10/2000
Decision Date 09/19/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-