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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 K972595
Device Name ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
Applicant
Avid N.I.T., Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
Avid N.I.T., Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Correspondent Contact JOSEPH E HARMS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received07/11/1997
Decision Date 05/20/1998
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
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