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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K955655
Device Name MIDWEST ONE
Applicant
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact HECTOR JIMENEZ
Correspondent
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact HECTOR JIMENEZ
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/12/1995
Decision Date 03/05/1996
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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