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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K983361
Device Name PANAVIA F
Applicant
Kuraray America, Inc.
200 Park Ave.
New York,  NY  10166 -3098
Applicant Contact KOJI FUJITA
Correspondent
Kuraray America, Inc.
200 Park Ave.
New York,  NY  10166 -3098
Correspondent Contact KOJI FUJITA
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/24/1998
Decision Date 11/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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