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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K961822
Device Name WET-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 Number872.3200
Classification Product Code
KLE  
Date Received05/10/1996
Decision Date 06/11/1996
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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