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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, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
510(k) Number K930335
Device Name PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
Applicant
Fittydent-Altwirth & Schmitt GmbH
333 W. Wacler Dr. Siote 2600
Chicago,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
Fittydent-Altwirth & Schmitt GmbH
333 W. Wacler Dr. Siote 2600
Chicago,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number872.3490
Classification Product Code
KOO  
Date Received01/22/1993
Decision Date 02/01/1994
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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