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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 K945965
Device Name ATRAUMATIC PENCIL POINT SPINAL NEEDLE
Applicant
Avid N.I.T., Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
Spectra Medical Devices, Inc.
299 Ballardvale St., Suite I,
Wilmington,  MA  01887
Correspondent Contact Kathy Dassler
Regulation Number868.5150
Classification Product Code
BSP  
Date Received12/07/1994
Decision Date 08/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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