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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K991259
Device Name TE ME NA EPIDURAL CATHETER
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 Number868.5120
Classification Product Code
BSO  
Date Received04/13/1999
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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