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 Injector And Syringe, Angiographic
510(k) Number K942381
Device Name LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
Applicant
Apogee, Inc.
7517-101 Precision Dr.
Raleigh,  NC  27613
Applicant Contact DIANE N PEPER
Correspondent
Apogee, Inc.
7517-101 Precision Dr.
Raleigh,  NC  27613
Correspondent Contact DIANE N PEPER
Regulation Number870.1650
Classification Product Code
DXT  
Date Received05/19/1994
Decision Date 03/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-