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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 -2575
Applicant Contact MEYER
Correspondent
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310 -2575
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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