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 Catheter, Ureteral, Gastro-Urology
510(k) Number K083788
Device Name ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
Applicant
Endooptiks, Inc.
39 Sycamore Ave.
Little Silver,  NJ  07739
Applicant Contact DONALD R WATSON
Correspondent
Endooptiks, Inc.
39 Sycamore Ave.
Little Silver,  NJ  07739
Correspondent Contact DONALD R WATSON
Regulation Number876.5130
Classification Product Code
EYB  
Date Received12/19/2008
Decision Date 03/03/2009
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
-
-