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FDA 510(k) Application Details - K992868
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K992868
Device Name
Unit, Operative Dental
Applicant
MRLB INTL., INC.
2450 COLLEGE WAY
FERGUS FALLS, MN 56537 US
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Contact
B.J. HAMMARBACK
Other 510(k) Applications for this Contact
Regulation Number
872.6640
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Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/1999
Decision Date
09/07/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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