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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 K800485
Device Name VINYL POLYSILOXANE IMPRESSION MATERIAL
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/04/1980
Decision Date 03/18/1980
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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