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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K040021
FOIA Releasable 510(k) K040021
Device Name SHUNTCHECK (PROMETHEUS 1)
Applicant
Samuel Neff M.D.
17 White Horse Pike
Suite 3
Haddon Heights,  NJ  08035
Applicant Contact SAMUEL NEFF
Correspondent
Samuel Neff M.D.
17 White Horse Pike
Suite 3
Haddon Heights,  NJ  08035
Correspondent Contact SAMUEL NEFF
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/06/2004
Decision Date 11/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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