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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 K945200
Device Name FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
Applicant
PROCTER & GAMBLE CO.
SHARON WOODS TECHNICAL CENTTER
11450 GROOMS ROAD
CINCINNATI,  OH  45242 -1434
Applicant Contact RANDALL A STOLT
Correspondent
PROCTER & GAMBLE CO.
SHARON WOODS TECHNICAL CENTTER
11450 GROOMS ROAD
CINCINNATI,  OH  45242 -1434
Correspondent Contact RANDALL A STOLT
Regulation Number872.3490
Classification Product Code
KOO  
Date Received10/25/1994
Decision Date 11/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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