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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K875082
Device Name O.P.C. INTRAVASCULAR CATHETER
Applicant
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Applicant Contact R. D KENSETH
Correspondent
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Correspondent Contact R. D KENSETH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/09/1987
Decision Date 03/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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