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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 K903568
Device Name SUPER STRENGTH DENTURE ADHESIVE CREAM
Applicant
Teledyne Getz
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Applicant Contact GABRIEL LEBOVIC
Correspondent
Teledyne Getz
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Correspondent Contact GABRIEL LEBOVIC
Regulation Number872.3490
Classification Product Code
KOT  
Date Received08/07/1990
Decision Date 10/24/1990
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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