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FDA 510(k) Application Details - K974238
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K974238
Device Name
Unit, Operative Dental
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY, MD 21801 US
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Contact
PARTHA BASUMALLIK
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
11/12/1997
Decision Date
02/04/1998
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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