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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K990100
Device Name POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
Applicant
TE ME NA S.A.R.L.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Applicant Contact JOE HARMS
Correspondent
TE ME NA S.A.R.L.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Correspondent Contact JOE HARMS
Regulation Number882.1350
Classification Product Code
GXZ  
Subsequent Product Code
CAZ  
Date Received01/04/1999
Decision Date 08/02/2000
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
Recalls CDRH Recalls
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