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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K913141
Device Name MEGA MYELOGRAM KIT
Applicant
Megadyne Medical Products, Inc.
P.O.Box 260956
Tampa,  FL  33685
Applicant Contact RAY VAHAB
Correspondent
Megadyne Medical Products, Inc.
P.O.Box 260956
Tampa,  FL  33685
Correspondent Contact RAY VAHAB
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/16/1991
Decision Date 10/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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