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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 K021196
Device Name NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
Applicant
NEURON THERAPEUTICS, INC.
81 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact JUDY P WAYS
Correspondent
NEURON THERAPEUTICS, INC.
81 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact JUDY P WAYS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/16/2002
Decision Date 07/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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