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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 K100915
Device Name INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
Applicant
Hutchinson Technology, Inc.
40 W. Highland Park Dr. NE
Hutchinson,  MN  55350
Applicant Contact COLIN MCGRAW
Correspondent
Hutchinson Technology, Inc.
40 W. Highland Park Dr. NE
Hutchinson,  MN  55350
Correspondent Contact COLIN MCGRAW
Regulation Number870.2700
Classification Product Code
MUD  
Date Received04/01/2010
Decision Date 04/30/2010
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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