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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, spinal-cord, implanted (pain relief)
510(k) Number K960728
Device Name ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
Applicant
NEUROMED, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002 -4211
Applicant Contact KRISTA OAKES
Correspondent
NEUROMED, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002 -4211
Correspondent Contact KRISTA OAKES
Regulation Number882.5880
Classification Product Code
GZB  
Date Received02/22/1996
Decision Date 05/22/1996
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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