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510(k) K850852

INFRARAX DEVICE by Medicon, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
March 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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