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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K920052
Device Name HEALTH PAK TRAY SOX BARRIERS
Applicant
Healthpak, Inc.
227 W. Monroe St.
49th Floor
Chicago,  IL  60606
Applicant Contact DENNIS M GRONEK
Correspondent
Healthpak, Inc.
227 W. Monroe St.
49th Floor
Chicago,  IL  60606
Correspondent Contact DENNIS M GRONEK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/06/1992
Decision Date 04/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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