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 ureteroscope and accessories, flexible/rigid
510(k) Number K023358
Device Name USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact TERRENCE SULLIVAN
Correspondent
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact TERRENCE SULLIVAN
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Code
FBN  
Date Received10/07/2002
Decision Date 01/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-