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FDA 510(k) Application Details - K101789
Device Classification Name
Catheter, Recording, Electrode, Reprocessed
More FDA Info for this Device
510(K) Number
K101789
Device Name
Catheter, Recording, Electrode, Reprocessed
Applicant
STERILMED, INC.
11400 73RD AVE. N.
MAPLE GROVE, MN 55369 US
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Contact
GARRETT AHLBORG
Other 510(k) Applications for this Contact
Regulation Number
870.1220
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Classification Product Code
NLH
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More FDA Info for this Product Code
Date Received
06/28/2010
Decision Date
08/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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