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 Dislodger, Stone, Flexible
510(k) Number K962676
Device Name DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact DEAN SECREST
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact DEAN SECREST
Regulation Number876.4680
Classification Product Code
FGO  
Date Received07/09/1996
Decision Date 10/04/1996
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
Recalls CDRH Recalls
-
-