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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K964755
Device Name MICROJET CAVITY PREPARATION SYSTEM
Applicant
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact HECTOR JIMENEZ-BILLINI
Correspondent
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact HECTOR JIMENEZ-BILLINI
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received11/27/1996
Decision Date 09/11/1997
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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