LUMBAR PUNCTURE KIT

Manometer, Spinal-fluid

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Lumbar Puncture Kit.

Pre-market Notification Details

Device IDK970287
510k NumberK970287
Device Name:LUMBAR PUNCTURE KIT
ClassificationManometer, Spinal-fluid
Applicant B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem,  PA  18018
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem,  PA  18018
Product CodeFMJ  
CFR Regulation Number880.2500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-24
Decision Date1997-04-07
Summary:summary

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