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FDA 510(k) Application Details - K974487
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K974487
Device Name
Unit, Operative Dental
Applicant
ASI MEDICAL, INC.
14550 EAST EASTER AVE.
SUITE 700
ENGLEWOOD, CO 80112 US
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Contact
JOHN W MCPEEK
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Regulation Number
872.6640
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Classification Product Code
EIA
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More FDA Info for this Product Code
Date Received
11/26/1997
Decision Date
02/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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