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 Retractor, Self-Retaining
510(k) Number K853119
Device Name URODYN 1000
Applicant
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact OLE STRANGE
Correspondent
DANTEC ELECTRONICS, INC.
6 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact OLE STRANGE
Regulation Number876.4730
Classification Product Code
FFO  
Date Received07/25/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-