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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 K870950
Device Name UNIPORT MODEL SD-60, SD-70
Applicant
Healthcare Technologies, Inc.
3300 Oakton St.
Skokie,  IL  60076
Applicant Contact JEFFREY A MCINTYRE
Correspondent
Healthcare Technologies, Inc.
3300 Oakton St.
Skokie,  IL  60076
Correspondent Contact JEFFREY A MCINTYRE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/10/1987
Decision Date 08/04/1987
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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