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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Dental, Intraoral
510(k) Number K905418
Device Name GATES GLIDDEN DRILLS
Applicant
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310
Applicant Contact MEYER
Correspondent
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310
Correspondent Contact MEYER
Regulation Number872.4130
Classification Product Code
DZA  
Date Received12/04/1990
Decision Date 07/25/1991
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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