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FDA 510(k) Application Details - K113201
Device Classification Name
Device, Jaw Repositioning
More FDA Info for this Device
510(K) Number
K113201
Device Name
Device, Jaw Repositioning
Applicant
RESMED SAS
9001 SPECTRUM CENTER BLVD.
SAN DIEGO, CA 92123 US
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Contact
DAVID D'CRUZ
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
LQZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2011
Decision Date
12/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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