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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K870015
Device Name HCI ALL PURPOSE DRAIN/CATHETER SET
Applicant
Health Care Innovations, Inc.
609 Dundee Rd.
Glencoe,  IL  60022
Applicant Contact CRAIG S STEADMAN
Correspondent
Health Care Innovations, Inc.
609 Dundee Rd.
Glencoe,  IL  60022
Correspondent Contact CRAIG S STEADMAN
Regulation Number878.4200
Classification Product Code
GBS  
Date Received01/02/1987
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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