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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K974097
Device Name PERIACRYL
Applicant
Blacklock Medical Products, Inc.
6671 London Court
Delta,  CA V4K 4W7
Applicant Contact DON BLACKLOCK
Correspondent
Blacklock Medical Products, Inc.
6671 London Court
Delta,  CA V4K 4W7
Correspondent Contact DON BLACKLOCK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received10/30/1997
Decision Date 04/09/1998
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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