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 Catheter, Retention Type, Balloon
510(k) Number K033830
Device Name OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
Applicant
Opticon Medical, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact GERARD J PRUD'HOMME, ESQ.
Correspondent
Opticon Medical, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME, ESQ.
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
KNX  
Date Received12/10/2003
Decision Date 01/09/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-