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FDA 510(k) Application Details - K041718
Device Classification Name
Headgear, Extraoral, Orthodontic
More FDA Info for this Device
510(K) Number
K041718
Device Name
Headgear, Extraoral, Orthodontic
Applicant
GREAT LAKES ORTHODONTICS, LTD.
200 COOPER AVE.
P.O. BOX 5111
TONAWANDA, NY 14151-5111 US
Other 510(k) Applications for this Company
Contact
DAVE GRAVER
Other 510(k) Applications for this Contact
Regulation Number
872.5500
More FDA Info for this Regulation Number
Classification Product Code
DZB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2004
Decision Date
10/15/2004
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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