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510(k) K943381

LASER ALIGNMENT TOOL by Philips Medical Systems North America, Inc. — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1994
Date Received
July 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

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