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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 K953270
Device Name MODEL 1100 MEDMATE INFUSION PUMP
Applicant
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Applicant Contact TOM KANE
Correspondent
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Correspondent Contact TOM KANE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/13/1995
Decision Date 10/07/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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