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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 K912445
Device Name MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
Applicant
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Applicant Contact ELLEN JOY
Correspondent
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Correspondent Contact ELLEN JOY
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received06/03/1991
Decision Date 10/18/1991
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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