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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 K912322
Device Name MEGA SPINAL ANESTHESIA KIT
Applicant
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Applicant Contact ELLEN JOOY
Correspondent
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Correspondent Contact ELLEN JOOY
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/24/1991
Decision Date 09/26/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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