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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K884245
Device Name PERFECT CHOICE
Applicant
Challenge Products, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
Challenge Products, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number872.3250
Classification Product Code
EJK  
Date Received10/11/1988
Decision Date 01/04/1989
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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