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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K972019
Device Name PEFECT SHOT
Applicant
International Imaging Electronics
881 Remington Blvd.
Bolingbrook,  IL  60440 -4932
Applicant Contact ROGER C CLAAR
Correspondent
International Imaging Electronics
881 Remington Blvd.
Bolingbrook,  IL  60440 -4932
Correspondent Contact ROGER C CLAAR
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/01/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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