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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K905640
Device Name SOLID CORE GUTTA PERCHA CARRIER
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 Number872.4565
Classification Product Code
EKS  
Date Received12/17/1990
Decision Date 03/05/1991
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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