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 anoscope and accessories
510(k) Number K091490
Device Name FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
Applicant
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
THD SPA
VIA BORGO SANTA CRISTINA 12
IMOLA, BO,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number876.1500
Classification Product Code
FER  
Date Received05/20/2009
Decision Date 06/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-