Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K001245
Device Name 3T L. V. CONTROL VALVE
Applicant
3T MEDICAL SYSTEMS, LLC.
6770 PINE WAY DR.
TROY,  MI  48098
Applicant Contact TIMOTHY J SIMMONS
Correspondent
3T MEDICAL SYSTEMS, LLC.
6770 PINE WAY DR.
TROY,  MI  48098
Correspondent Contact TIMOTHY J SIMMONS
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received04/18/2000
Decision Date 08/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-