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FDA 510(k) Application Details - K982009
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K982009
Device Name
Unit, Operative Dental
Applicant
SCITECH SOLUTIONS, INC.
562 1ST AVENUE SOUTH #700
SEATTTLE, WA 98104 US
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Contact
CLIVE M DEFTY
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
04/02/1998
Decision Date
06/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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