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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 K981490
Device Name WILLI GELLER CREATION PORCELAIN
Applicant
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Applicant Contact JOHN SLANSKI
Correspondent
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Correspondent Contact JOHN SLANSKI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/27/1998
Decision Date 10/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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