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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name controller, infusion, intravascular, electronic
510(k) Number K905498
Device Name STAT 2 IV PUMPETTE
Applicant
THE MASTER MEDICAL CORP.
201 SPEAR ST.
SUITE 1111
SAN FRANCISCO,  CA  94105
Applicant Contact CHARLES L MORIN
Correspondent
THE MASTER MEDICAL CORP.
201 SPEAR ST.
SUITE 1111
SAN FRANCISCO,  CA  94105
Correspondent Contact CHARLES L MORIN
Regulation Number880.5725
Classification Product Code
LDR  
Date Received12/07/1990
Decision Date 04/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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