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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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