FDA 510(k) Application Details - K020298

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K020298
Device Name Neurological Stereotaxic Instrument
Applicant PLUS ORTHOPEDICS
6055 LUSK BLVD.
SAN DIEGO, CA 92121-2700 US
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Contact HARTMUT LOCH
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 01/28/2002
Decision Date 05/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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