• 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 Endoscopic Irrigation/Suction System
510(k) Number K103239
Device Name IRRIGATION SYSTEM
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact CARROLL L MARTIN
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact CARROLL L MARTIN
Regulation Number876.1500
Classification Product Code
OCX  
Date Received11/02/2010
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-