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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K913382
Device Name MEGA PARACENTESIS 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 Number878.4370
Classification Product Code
KKX  
Date Received07/29/1991
Decision Date 10/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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