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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 K831493
Device Name DENTURE ADHESIVE SEALS
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Regulation Number872.3490
Classification Product Code
KOT  
Date Received05/10/1983
Decision Date 06/30/1983
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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