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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 Rd.
Cincinnati,  OH  45242
Applicant Contact RANDALL A STOLT
Correspondent
Procter & Gamble Co.
Sharon Woods Technical Centter
11450 Grooms Rd.
Cincinnati,  OH  45242
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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