FDA 510(k) Application Details - K982009

Device Classification Name Unit, Operative Dental

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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
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Regulation Number 872.6640

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Classification Product Code EIA
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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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