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 gastroscope and accessories, flexible/rigid
510(k) Number K140295
Device Name GIS ENDOSCOPIC OPTICAL LENS
Applicant
GI SCIENTIFIC LLC
128 Blye HIll Landing
Newbury,  NH  03255
Applicant Contact MICHELE LUCEY
Correspondent
GI SCIENTIFIC LLC
128 Blye HIll Landing
Newbury,  NH  03255
Correspondent Contact MICHELE LUCEY
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FEI  
Date Received02/06/2014
Decision Date 07/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-