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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K990323
Device Name TE ME NA POLYSTIM NERVE STIMILATOR
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 Number868.2775
Classification Product Code
BXN  
Date Received02/02/1999
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
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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