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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 K881826
Device Name ENDO-ICE
Applicant
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310
Applicant Contact T. N MEYER
Correspondent
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310
Correspondent Contact T. N MEYER
Regulation Number872.1720
Classification Product Code
EAT  
Date Received04/29/1988
Decision Date 08/23/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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