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510(k) K141564

OPTON PRO by Zimmer Medizinsystems GmbH — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2014
Date Received
June 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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