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FDA 510(k) Application Details - K992269
Device Classification Name
Block, Bite
More FDA Info for this Device
510(K) Number
K992269
Device Name
Block, Bite
Applicant
SOMATICS, INC.
910 SHERWOOD DR., UNIT 17
LAKE BLUFF, IL 60044 US
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Contact
RICHARD ABRAMS
Other 510(k) Applications for this Contact
Regulation Number
882.5070
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Classification Product Code
JXL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/1999
Decision Date
10/25/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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