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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 K023938
Device Name MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
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 Received11/26/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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