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FDA 510(k) Application Details - K991199
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K991199
Device Name
Electrode, Cutaneous
Applicant
BIOMED PRODUCTS
5262 VISTA GRANDE DR.
SANTA ROSA, CA 95403 US
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Contact
TIMOTHY THYGESON
Other 510(k) Applications for this Contact
Regulation Number
882.1320
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Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/1999
Decision Date
06/22/1999
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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