
Hutchinson Technology, Inc.
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MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 is an FDA 510(k)-cleared medical device (K023938) manufactured by Hutchinson Technology, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2002. Regulation: 8.