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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K102526
Device Name BLO2X OXYGEN BLOCKER
Applicant
Pascal Co., Inc.
2929 NE Northup Way
Bellevue,  WA  98004
Applicant Contact VINCENT M TENTARELLI
Correspondent
Pascal Co., Inc.
2929 NE Northup Way
Bellevue,  WA  98004
Correspondent Contact VINCENT M TENTARELLI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/02/2010
Decision Date 10/22/2010
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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