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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 K073568
Device Name PSL BIOZIR BLOCK
Applicant
P.S.L. International, Inc.
1424 Hymus, Suite
Dorval Quebec,  CA H2P 1J6
Applicant Contact CATHERINE FENG
Correspondent
P.S.L. International, Inc.
1424 Hymus, Suite
Dorval Quebec,  CA H2P 1J6
Correspondent Contact CATHERINE FENG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/20/2007
Decision Date 02/06/2008
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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