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FDA 510(k) Application Details - K162948
Device Classification Name
Cord, Retraction
More FDA Info for this Device
510(K) Number
K162948
Device Name
Cord, Retraction
Applicant
KERR CORPORATION
1717 W. COLLINS AVE.
ORANGE, CA 92867 US
Other 510(k) Applications for this Company
Contact
Jennifer Dzidrums
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MVL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2016
Decision Date
08/08/2017
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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