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FDA 510(k) Application Details - K082294
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K082294
Device Name
Unit, Operative Dental
Applicant
WESTAR MEDICAL PRODUCTS, INC.
4470 CHENNAULT BEACH RD
SUITE 2
MUKILTEO, WA 98275 US
Other 510(k) Applications for this Company
Contact
RUTH HALLER
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
08/12/2008
Decision Date
08/22/2008
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
Y
Expedited Review
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