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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 K946047
Device Name HOLGRATH METAL-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 Received12/12/1994
Decision Date 07/25/1995
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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