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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K850863
Device Name ULTRAFIL-LT (GUTTA PERCHA)
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 Number872.3850
Classification Product Code
EKM  
Date Received03/01/1985
Decision Date 04/16/1985
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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