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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K913397
Device Name MEGA ANGIOGRAM KIT
Applicant
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Applicant Contact RAY VAHAB
Correspondent
Mega Medical, Inc.
P.O.Box 260956
Tampa,  FL  33685
Correspondent Contact RAY VAHAB
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/30/1991
Decision Date 10/31/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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