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FDA 510(k) Application Details - K944598
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K944598
Device Name
Media, Electroconductive
Applicant
CHESTER LABS, INC.
1900 SECTION RD., SUITE A
CINCINNATI, OH 45237 US
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Contact
HOLLY SHERWOOD
Other 510(k) Applications for this Contact
Regulation Number
882.1275
More FDA Info for this Regulation Number
Classification Product Code
GYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/1994
Decision Date
05/07/1996
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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