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FDA 510(k) Application Details - K001048
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K001048
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
RELIANCE ORTHODONTIC PRODUCTS, INC.
1100 W. IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact
KATHRYN B PATTERSON
Other 510(k) Applications for this Contact
Regulation Number
872.3750
More FDA Info for this Regulation Number
Classification Product Code
DYH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2000
Decision Date
04/27/2000
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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