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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K013231
Device Name AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
Applicant
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Applicant Contact SCOTT HENDERSON
Correspondent
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR,  FL  34677
Correspondent Contact SCOTT HENDERSON
Regulation Number868.5150
Classification Product Code
BSP  
Date Received09/27/2001
Decision Date 12/03/2001
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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