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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pulp
510(k) Number K930764
Device Name ENDO-ICE-PULP TESTER-THERMAL
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 Number872.1720
Classification Product Code
EAT  
Date Received02/12/1993
Decision Date 05/27/1993
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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