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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 K070114
Device Name CREATION CP-ZI PORCELAIN
Applicant
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Applicant Contact GARY PHELPS
Correspondent
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Correspondent Contact GARY PHELPS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/12/2007
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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