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 Tube, Tracheal (W/Wo Connector)
510(k) Number K000045
Device Name POSITUBE
Applicant
PARAPRODUCTS, INC.
1431 INDUSTRIAL DR.
ITASCA,  IL  60143
Applicant Contact JAMES FLORY
Correspondent
PARAPRODUCTS, INC.
1431 INDUSTRIAL DR.
ITASCA,  IL  60143
Correspondent Contact JAMES FLORY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/07/2000
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-