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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manometer, Spinal-Fluid
510(k) Number K970287
Device Name LUMBAR PUNCTURE KIT
Applicant
B.Braun Medical, Inc.
824 12th Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B.Braun Medical, Inc.
824 12th Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number880.2500
Classification Product Code
FMJ  
Date Received01/24/1997
Decision Date 04/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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