FDA 510(k) Application Details - K953124

Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)

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510(K) Number K953124
Device Name Holder, Head, Neurosurgical (Skull Clamp)
Applicant OHIO MEDICAL INSTRUMENT CO., INC.
3924 VIRGINIA AVE.
CINCINNATI, OH 45227 US
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Contact F. WILLIAM SWEET
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Regulation Number 882.4460

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Classification Product Code HBL
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Date Received 07/05/1995
Decision Date 02/09/1996
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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