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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K912540
Device Name CONTOUR-PORT
Applicant
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact LORNA K LINVILLE
Correspondent
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact LORNA K LINVILLE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/10/1991
Decision Date 08/23/1991
Decision Substantially Equivalent - Kit (SESK)
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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