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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 K941342
Device Name PAIN DOC
Applicant
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number882.5880
Classification Product Code
GZB  
Date Received02/22/1994
Decision Date 10/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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