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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 K945671
Device Name CONTINUOUS EPIDURAL ANESTHESIA TRAY
Applicant
TRINITY LABORATORIES, INC.
201 KELLY DR.
SALISBURY,  MD  21801
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
201 KELLY DR.
SALISBURY,  MD  21801
Correspondent Contact PARTHA BASUMALLIK
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/18/1994
Decision Date 02/16/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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