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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 STREET, NW
WASHINGTON,  DC  20004
Applicant Contact GERARD J PRUD'HOMME, ESQ.
Correspondent
OPTICON MEDICAL, INC.
555 THIRTEENTH STREET, 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
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