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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K904484
Device Name BAXTER SINGLE PATIENT USE PRESSURE INFUSOR
Applicant
TECNADYNE SCIENTIFIC, INC.
740C FOURTEENTH ST.
VERO BEACH,  FL  32960
Applicant Contact JOHN GARRETT
Correspondent
TECNADYNE SCIENTIFIC, INC.
740C FOURTEENTH ST.
VERO BEACH,  FL  32960
Correspondent Contact JOHN GARRETT
Regulation Number880.5420
Classification Product Code
KZD  
Date Received10/02/1990
Decision Date 10/26/1990
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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