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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 K032455
Device Name PANAVIA F 2.0
Applicant
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Applicant Contact SATOSHI YAMAGUCHI
Correspondent
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Correspondent Contact SATOSHI YAMAGUCHI
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/11/2003
Decision Date 11/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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