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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium
510(k) Number K945462
Device Name SUPER POLI-GRIP DENTURE ADHESIVE CREAM
Applicant
BLOCK DRUG COMPANY, INC.
257 CORNELISON AVE.
JERSEY CITY,  NJ  07302
Applicant Contact FILOMENA KING
Correspondent
BLOCK DRUG COMPANY, INC.
257 CORNELISON AVE.
JERSEY CITY,  NJ  07302
Correspondent Contact FILOMENA KING
Regulation Number872.3490
Classification Product Code
KOT  
Date Received11/07/1994
Decision Date 12/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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