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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 K843033
Device Name DESERET INTRAVASCULAR CATHETER
Applicant
Parke-Davis Co.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact CLEARLY
Correspondent
Parke-Davis Co.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact CLEARLY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/01/1984
Decision Date 12/03/1984
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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