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510(k) K031597

DUNLEE FORMAT COLLIMATOR FAMILY by Philips Medical Systems North America Co. — Product Code IZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2003
Date Received
May 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Automatic, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

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