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FDA 510(k) Application Details - K050188
Device Classification Name
Block, Bite
More FDA Info for this Device
510(K) Number
K050188
Device Name
Block, Bite
Applicant
EPISAFE MEDICAL DEVICES, LTD.
291 Hillside Avenue
Somerset, MA 02726 US
Other 510(k) Applications for this Company
Contact
GEORGE J HATTUB
Other 510(k) Applications for this Contact
Regulation Number
882.5070
More FDA Info for this Regulation Number
Classification Product Code
JXL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2005
Decision Date
04/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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