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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K945370
Device Name C-POST
Applicant
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Applicant Contact JAMES L SANDRIK
Correspondent
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Correspondent Contact JAMES L SANDRIK
Regulation Number872.3810
Classification Product Code
ELR  
Date Received11/02/1994
Decision Date 03/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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