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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 K891919
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
MULTI-MED, INC.
P.O. BOX 660
WEST SWANZEY,  NH  03469
Applicant Contact ALAN P REID
Correspondent
MULTI-MED, INC.
P.O. BOX 660
WEST SWANZEY,  NH  03469
Correspondent Contact ALAN P REID
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/27/1989
Decision Date 05/05/1989
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
Recalls CDRH Recalls
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