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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K940908
Device Name DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS
Applicant
Dunhall Pharmaceuticals, Inc.
P.O. Box 100
Gravette,  AR  72736
Applicant Contact MONTE J STAHA
Correspondent
Dunhall Pharmaceuticals, Inc.
P.O. Box 100
Gravette,  AR  72736
Correspondent Contact MONTE J STAHA
Regulation Number872.4535
Classification Product Code
DZP  
Date Received02/24/1994
Decision Date 08/29/1994
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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