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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K901938
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 Number876.5090
Classification Product Code
KOB  
Date Received04/30/1990
Decision Date 06/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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