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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K042020
Device Name SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
Applicant
Hutchinson Technology, Inc.
40 W. Highland Park
Hutchinson,  MN  55350
Applicant Contact THOMAS A DOLD
Correspondent
Hutchinson Technology, Inc.
40 W. Highland Park
Hutchinson,  MN  55350
Correspondent Contact THOMAS A DOLD
Regulation Number870.2700
Classification Product Code
MUD  
Date Received07/27/2004
Decision Date 09/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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