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510(k) K915577

Device
IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE
Applicant
IMPRA, INC.
510(k) number
K915577
Product code
CAR  
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-11
Date received
1991-12-13
Regulation
880.2460
Classification name
Monitor, Spinal-fluid Pressure, Electrically Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICH KAUFMAN
Address
1625 W. 3rd St. P.O. Box 1740 Tempe AZ US 85281 85281

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920740EPISENSOR PLUSIndustrias Palex C/O Dma Med-Chem Corp.1994-03-07
K926066BION MUMPS-G ANTIBODY TEST SYSTEMBion Ent., Ltd.1993-06-15

Legacy Summary#

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FDA Review#

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