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 Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K090197
Device Name EG-3870UTK
Applicant
PENTAX MEDICAL COMPANY
102 CHESTNUT RIDGE RD.
MONTVALE,  NJ  07645 -1856
Applicant Contact PAUL SILVA
Correspondent
PENTAX MEDICAL COMPANY
102 CHESTNUT RIDGE RD.
MONTVALE,  NJ  07645 -1856
Correspondent Contact PAUL SILVA
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received01/27/2009
Decision Date 05/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-