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510(k) K901225

Device
Life Shield (disposable Pressure Infusor)
Applicant
ABBOTT LABORATORIES
510(k) number
K901225
Product code
KZD
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-23
Date received
1990-03-14
Regulation
880.5420
Classification name
Infusor, Pressure, For I.V. Bags
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FREDERICK GUSTAFSON
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KZD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.1998-02-17
K973843MSI PRESSURE INFUSORSmith Assoc.1997-10-29
K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.1995-10-07
K951988PRESSURIZERPromedic, Inc.1995-06-14
K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.1994-08-25
K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.1993-12-14
K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, Inc.1993-04-21
K913751PRESSURE INFUSERBiomedical Dynamics, Inc.1992-01-09
K910926TECNADYNE SURGI-SQUEEZE INFUSION PUMPTecnadyne Scientific, Inc.1991-08-02
K911216INFUSABLEBiomedical Dynamics, Inc.1991-07-22
K904484BAXTER SINGLE PATIENT USE PRESSURE INFUSORTecnadyne Scientific, Inc.1990-10-26
K894927SURGI SQUEEZEthox Corp.1989-09-11
K881977PRESSURE INFUSORPrimrose Medical, Inc.1988-07-29
K874454IV-PUSH, CONSTANT INFUSION PUMPMedical Products Search, Inc.1987-11-06
K861977BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSORBiomedical Dynamics, Inc.1986-07-15