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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Non-Tilting, Powered
510(k) Number K893452
Device Name EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
Applicant
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact CLARK, PHD
Correspondent
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact CLARK, PHD
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received05/03/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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