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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 K941365
Device Name MPI DENTURE ADHESIVE FILM SEALS
Applicant
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Applicant Contact THOMAS VANNE
Correspondent
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Correspondent Contact THOMAS VANNE
Regulation Number872.3490
Classification Product Code
KOT  
Date Received03/21/1994
Decision Date 04/22/1994
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
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