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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 K923290
Device Name COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE
Applicant
A Mixed Bag Corp.
40 St. Clair Dr.
Pittsburgh,  PA  15228
Applicant Contact TEEPLE JR.
Correspondent
A Mixed Bag Corp.
40 St. Clair Dr.
Pittsburgh,  PA  15228
Correspondent Contact TEEPLE JR.
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/06/1992
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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