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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K992868
Device Name DENTAPURE DP40 CARTRIDGE
Applicant
Mrlb Intl., Inc.
2450 College Way
Fergus Falls,  MN  56537
Applicant Contact B.J. HAMMARBACK
Correspondent
Mrlb Intl., Inc.
2450 College Way
Fergus Falls,  MN  56537
Correspondent Contact B.J. HAMMARBACK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/26/1999
Decision Date 09/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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