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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
510(k) Number K895818
Device Name STEADFAST DENTURE ADHESIVE CREAM
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 Number872.3490
Classification Product Code
KOT  
Date Received09/29/1989
Decision Date 04/03/1990
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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