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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K900209
Device Name WILLI GELLER CERAMIC CREATION & SURPRISE
Applicant
Creation North America, Inc.
100 E. Wisconsin Ave.
Milwaukee,  WI  53202
Applicant Contact FRANK J PELISEK
Correspondent
Creation North America, Inc.
100 E. Wisconsin Ave.
Milwaukee,  WI  53202
Correspondent Contact FRANK J PELISEK
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/17/1990
Decision Date 04/09/1990
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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