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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Flexible
510(k) Number K921295
Device Name INTRAVENOUS CATHETERS MODIFICATIONS
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact JOHN MATSON
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact JOHN MATSON
Regulation Number876.4680
Classification Product Code
FGO  
Date Received03/12/1992
Decision Date 05/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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