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 K033191
Device Name SOHNIKS
Applicant
Sohniks Endoscopy, Inc.
930 Blue Gentian Rd.
Suite 1400
Eagan,  MN  55121
Applicant Contact MARC HOSKINS
Correspondent
Sohniks Endoscopy, Inc.
930 Blue Gentian Rd.
Suite 1400
Eagan,  MN  55121
Correspondent Contact MARC HOSKINS
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received10/01/2003
Decision Date 03/09/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-