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 prosthesis, esophageal
510(k) Number K030559
Device Name RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
Applicant
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number878.3610
Classification Product Code
ESW  
Date Received02/21/2003
Decision Date 06/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-