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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K885231
Device Name KITCHIN DENTAL ABCESS DRAIN
Applicant
Kitchin, Inc.
5098 Rootstown Rd.
Ravenna,  OH  44266
Applicant Contact CHRISTOPHER KITCHIN
Correspondent
Kitchin, Inc.
5098 Rootstown Rd.
Ravenna,  OH  44266
Correspondent Contact CHRISTOPHER KITCHIN
Regulation Number872.6300
Classification Product Code
EIE  
Date Received12/20/1988
Decision Date 05/16/1989
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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