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 Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K910671
Device Name MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
Applicant
Solos Endoscopy, Inc.
6191 Atlantic Blvd. Suite 4
Norcross,  GA  30071
Applicant Contact WILLIAM F MEYER
Correspondent
Solos Endoscopy, Inc.
6191 Atlantic Blvd. Suite 4
Norcross,  GA  30071
Correspondent Contact WILLIAM F MEYER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/15/1991
Decision Date 05/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-