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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K970484
Device Name ACCU-PREP
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 Number872.6080
Classification Product Code
KOJ  
Date Received02/10/1997
Decision Date 07/01/1997
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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