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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K915231
Device Name EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
Applicant
Q-LIFE SYSTEMS, INC.
1180 CLYDE COURT
KINGSTON, ONTARIO,  CA K7P 2E4
Applicant Contact TIMOTHY SMITH
Correspondent
Q-LIFE SYSTEMS, INC.
1180 CLYDE COURT
KINGSTON, ONTARIO,  CA K7P 2E4
Correspondent Contact TIMOTHY SMITH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/22/1991
Decision Date 01/22/1992
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
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