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 Sigmoidoscope, Rigid, Non-Electrical
510(k) Number K070915
Device Name SAPIMED DISPOSABLE SIGMOIDOSCOPE
Applicant
Sapimed S.P.A.
1676 Village Green Suite A
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Sapimed S.P.A.
1676 Village Green Suite A
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number876.1500
Classification Product Code
KDM  
Date Received04/02/2007
Decision Date 07/06/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-