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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Coating, Filling Material, Resin
510(k) Number K850610
Device Name PEPSODENT DENTURE ADHESIVE CREAM
Applicant
Lever Brothers Company, Inc.
45 River Rd.
Edgewater,  NJ  07020
Applicant Contact FRANK H HEALEY
Correspondent
Lever Brothers Company, Inc.
45 River Rd.
Edgewater,  NJ  07020
Correspondent Contact FRANK H HEALEY
Regulation Number872.3310
Classification Product Code
EBD  
Date Received02/15/1985
Decision Date 05/15/1985
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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