• 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 catheter, continuous flush
510(k) Number K761273
Device Name FLUSHFLO-MODEL CC1-6
Applicant
BENTLEY LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
BENTLEY LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/20/1976
Decision Date 01/12/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-