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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K973800
Device Name 23:1 REDUCTION ANGLE
Applicant
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact ROBERT E BOOTH
Correspondent
Midwest Dental Products Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact ROBERT E BOOTH
Regulation Number872.4200
Classification Product Code
EGS  
Date Received10/06/1997
Decision Date 03/11/1998
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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