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510(k) K951372

Device
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
Applicant
Philips Medical Systems, Inc.
510(k) number
K951372
Product code
IZW
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-04
Date received
1995-03-27
Regulation
892.1610
Classification name
Collimator, Automatic, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PETER ALTMAN
Address
710 Bridgeport Ave. P.O. Box 860 Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K031597DUNLEE FORMAT COLLIMATOR FAMILYPhilips Medical Systems North America Co.2003-07-21
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K911127COLLIMASTER-90Varian Assoc., Inc.1991-09-19