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 catheters, suction, tracheobronchial
510(k) Number K922843
Device Name DYNAREX SUCTION CATHETERS & KITS
Applicant
DYNAREX CORP.
ONE INTERNATIONAL BLVD.
BREWSTER,  NY  10509
Applicant Contact RANDELL GREEN
Correspondent
DYNAREX CORP.
ONE INTERNATIONAL BLVD.
BREWSTER,  NY  10509
Correspondent Contact RANDELL GREEN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/12/1992
Decision Date 01/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-