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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 K954428
Device Name SOLOPICC 24 (60CM) 20GA CATHETER
Applicant
Douglas Medical Products Corp.
1840 Industrial Dr., Suite 200
Libertyville,  IL  60048
Applicant Contact RONALD HASELHORST
Correspondent
Douglas Medical Products Corp.
1840 Industrial Dr., Suite 200
Libertyville,  IL  60048
Correspondent Contact RONALD HASELHORST
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/22/1995
Decision Date 03/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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