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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Acacia And Karaya With Sodium Borate
510(k) Number K910216
Device Name STEADFAST DENTURE ADHESIVE POWDER
Applicant
Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Applicant Contact CARR, JR.
Correspondent
Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Correspondent Contact CARR, JR.
Regulation Number872.3400
Classification Product Code
KOM  
Date Received01/17/1991
Decision Date 03/29/1991
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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