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510(k) K110326

OSRAM ITOS by Osram Sylvania, Inc. — Product Code ERA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
February 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

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