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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K912564
Device Name MEGA PERICARDIOCENTESIS 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 Number870.1250
Classification Product Code
DQY  
Date Received06/11/1991
Decision Date 09/05/1991
Decision Substantially Equivalent (SESE)
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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