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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Dental, With Operative Unit
510(k) Number K923306
Device Name HEALTHPAK UTILITY 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 Number872.6250
Classification Product Code
KLC  
Date Received05/08/1992
Decision Date 08/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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