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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K931096
Device Name DURAFLOR
Applicant
Pharmascience, Inc.
C/O Cheng & Associates, Inc.
680 N. Lake Shore Dr., Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Pharmascience, Inc.
C/O Cheng & Associates, Inc.
680 N. Lake Shore Dr., Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3260
Classification Product Code
LBH  
Date Received03/03/1993
Decision Date 05/27/1993
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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