FDA 510(k) Application Details - K963570

Device Classification Name Manometer, Spinal-Fluid

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510(K) Number K963570
Device Name Manometer, Spinal-Fluid
Applicant SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE, NH 03431 US
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Contact TIMOTHY J TALCOTT
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Regulation Number 880.2500

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Classification Product Code FMJ
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Date Received 09/05/1996
Decision Date 10/18/1996
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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