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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Administration, Intravascular
510(k) Number K925927
Device Name MPC-1000 INJECTION CAP/PLUG
Applicant
MOLDED PRODUCTS INC.
1600 CHATBURN AVE.
P.O. BOX 15
HARLAN,  IA  51537
Applicant Contact REBECCA WILL
Correspondent
MOLDED PRODUCTS INC.
1600 CHATBURN AVE.
P.O. BOX 15
HARLAN,  IA  51537
Correspondent Contact REBECCA WILL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/23/1992
Decision Date 08/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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