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FDA 510(k) Application Details - K974542
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K974542
Device Name
Unit, Operative Dental
Applicant
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD, CO 80112 US
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Contact
EDWIN L ADAIR
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
12/03/1997
Decision Date
02/17/1998
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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