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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 K931027
Device Name BULLETT PERIPHERAL INFUSION CATHETER
Applicant
CARDIO-DYNAMICS, INC.
15 HAMMOND
SUITE 307
IRVINE,  CA  92718
Applicant Contact MICHAEL CROCKER
Correspondent
CARDIO-DYNAMICS, INC.
15 HAMMOND
SUITE 307
IRVINE,  CA  92718
Correspondent Contact MICHAEL CROCKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/01/1993
Decision Date 02/04/1994
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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