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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 K842133
Device Name EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS
Applicant
Cardio Search, Inc.
2007 Pan Am Cir.
Tampa,  FL  33623
Applicant Contact LARRY H BRIM
Correspondent
Cardio Search, Inc.
2007 Pan Am Cir.
Tampa,  FL  33623
Correspondent Contact LARRY H BRIM
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/30/1984
Decision Date 02/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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