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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 K945142
Device Name POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
Applicant
Scican
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Applicant Contact EVA YOUNG
Correspondent
Scican
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Correspondent Contact EVA YOUNG
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/20/1994
Decision Date 01/11/1995
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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