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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K915863
Device Name MEGA AMNIOCENTESIS 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 Number884.1550
Classification Product Code
HIO  
Date Received12/31/1991
Decision Date 03/30/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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