FDA 510(k) Application Details - K970287

Device Classification Name Manometer, Spinal-Fluid

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510(K) Number K970287
Device Name Manometer, Spinal-Fluid
Applicant B. BRAUN MEDICAL, INC.
824 12TH AVE.
BETHLEHEM, PA 18018 US
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Contact MARK S ALSBERGE
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Regulation Number 880.2500

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Classification Product Code FMJ
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Date Received 01/24/1997
Decision Date 04/07/1997
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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