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 cystoscope and accessories, flexible/rigid
510(k) Number K090814
Device Name MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact GRAHAM A.L. BAILLIE
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact GRAHAM A.L. BAILLIE
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received03/25/2009
Decision Date 04/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-