FDA 510(k) Application Details - K002276

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

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510(K) Number K002276
Device Name Holder, Head, Neurosurgical (Skull Clamp)
Applicant V. MUELLER NEURO/SPINE
360 INDUSTRIAL RD., UNIT H
SAN CARLOS, CA 94070 US
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Contact GARY COOPER
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Regulation Number 882.4460

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Classification Product Code HBL
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Date Received 07/26/2000
Decision Date 08/29/2000
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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