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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessories, catheter
510(k) Number K870014
Device Name HCI GENERAL PURPOSE CATHETER STYLET
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
KGZ  
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
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