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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 K910089
Device Name MEGA LUMBAR PUNCTURE KIT
Applicant
Megadyne Medical Products, Inc.
P.O.Box 260956
Tampa,  FL  33685
Applicant Contact ELLEN JOY
Correspondent
Megadyne Medical Products, Inc.
P.O.Box 260956
Tampa,  FL  33685
Correspondent Contact ELLEN JOY
Regulation Number880.2500
Classification Product Code
FMJ  
Date Received01/09/1991
Decision Date 06/20/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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