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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 K881671
Device Name MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT
Applicant
Manan Medical Devices
8020 N. Central Park Ave.
Skokie,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
Manan Medical Devices
8020 N. Central Park Ave.
Skokie,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/18/1988
Decision Date 06/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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