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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. EAST
TARPON SPRINGS,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
AVID N.I.T., INC.
917 KLOSTERMAN RD. EAST
TARPON SPRINGS,  FL  34689
Correspondent Contact JOSEPH E HARMS
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
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