FDA 510(k) Application Details - K053618

Device Classification Name Oximeter, Tissue Saturation

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510(K) Number K053618
Device Name Oximeter, Tissue Saturation
Applicant HUTCHINSON TECHNOLOGY, INC.
40 WEST HIGHLAND PARK
HUTCHINSON, MN 55350 US
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Contact JOSEPH P ORTNER
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Regulation Number 870.2700

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Classification Product Code MUD
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Date Received 12/28/2005
Decision Date 02/08/2006
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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