FDA 510(k) Application Details - K032432

Device Classification Name Manometer, Spinal-Fluid

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510(K) Number K032432
Device Name Manometer, Spinal-Fluid
Applicant BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 2156
HUNTINGTON, CT 06484 US
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Contact JOSEPH M AZARY
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Regulation Number 880.2500

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Classification Product Code FMJ
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Date Received 08/06/2003
Decision Date 08/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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