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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 K944906
Device Name HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
Applicant
HOLGRATH MEDICAL TECHNOLOGIES, INC.
30 KNOTTER DR.
CHESHIRE,  CT  06410
Applicant Contact R P HENDERSHOT
Correspondent
HOLGRATH MEDICAL TECHNOLOGIES, INC.
30 KNOTTER DR.
CHESHIRE,  CT  06410
Correspondent Contact R P HENDERSHOT
Regulation Number868.5150
Classification Product Code
BSP  
Date Received10/05/1994
Decision Date 06/07/1995
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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