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FDA 510(k) Application Details - K003422
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K003422
Device Name
Cleanser, Root Canal
Applicant
SUPER GLIDE, INC.
227 COLCHESTER AVE.
BURLINGTON, VT 05401 US
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Contact
VICTOR L RATKUS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/2000
Decision Date
01/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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