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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K923307
Device Name HEALTHPAK X-RAY 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 Number872.1810
Classification Product Code
EAP  
Date Received05/08/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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