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FDA 510(k) Application Details - K981171
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K981171
Device Name
Unit, Operative Dental
Applicant
THERATECHNOLOGIES, INC.
630,BOUL. RENE-LEVESQUE QUEST
5E ETAGE
MONTREAL QUEBEC H3B 1S6 CA
Other 510(k) Applications for this Company
Contact
ANDRE DE VILLERS
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/1998
Decision Date
12/02/1998
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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