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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 -3800
Applicant Contact JOHN MATSON
Correspondent
CRITIKON COMPANY,LLC
4110 GEORGE RD.
P.O. BOX 31800
TAMPA,  FL  33631 -3800
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
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