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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K954835
Device Name HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
Applicant
HOLGRATH MEDICAL TECHNOLOGIES, INC.
30 KNOTTER DR.
CHESHIRE,  CT  06410
Applicant Contact ROBERT P HENDERSHOT
Correspondent
HOLGRATH MEDICAL TECHNOLOGIES, INC.
30 KNOTTER DR.
CHESHIRE,  CT  06410
Correspondent Contact ROBERT P HENDERSHOT
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received10/20/1995
Decision Date 01/31/1996
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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