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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K901681
Device Name FORMASIL(R)A POLYVINYL SILOXANE LINE
Applicant
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/11/1990
Decision Date 06/15/1990
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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